DDrare: Database of Drug Development for Rare Diseases

Searched query = "Ankylosing spondylitis", "Spondylarthritis ankylopoietica"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid; 0881; 150 mg double-blinded secukinumab; 150 mg open-label secukinumab; 300 mg double-blinded secukinumab; 331731-18-1; 40 mg MSB11022; 42942019; 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin; 5057732; 99mTc-rhAnnexin V-128; ABATACEPT; ABT-494; ADALIMUMAB; AIN457; AIN457, 150 mg; AIN457, 75 mg; AIN457A; AIN457F; ARCOXIA; ARCOXIA 90 mg comprimidos recubiertos con película; ARRY-371797; ARRY-371797, p38 inhibitor; AS; ATORVASTATIN; Abatacept; Acetaminophen; Aclasta; Adalimumab; Adalimumab (D2E7); Adalimumab (Humira); Adalimumab 40 mg sc every other week; Adalimumab, Etanercept, Golimumab or infliximab; Alendronate; Anti TNF alpha agent; Anti TNF alpha therapy; Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain); Anti-Human Interleukin-23 Monoclonal Antibody; Anti-TNF; Anti-TNF biologics; Anti-TNF therapy (etanercept or adalimumab); Anti-Tumor Necrosis Factor; Apremilast; Apremilast tablet 20 mg; Apremilast tablet 30 mg BID; Arcoxia; Atorvastatin; BAT1406; BCD-055; BCD-085; BDMARD treatment; BI 655066; BI 655066 90 mg/ml; BI 730357; BIMEKIZUMAB; BMS-188667; BMS-986251; Bawei Shenqi Pill; Behavioral: AbbVie Care 2.0; Behavioral: Cannabis questionnaire; Behavioral: General healthy eating; Behavioral: Low Starch Diet (LSD); Bimekizumab; Biologic DMARD; Biosimilar; Blood collection; Blood samples; CA2; CANNABIDIOL; CC; CC-10004; CDP870; CERTOLIZUMAB PEGOL; CIMZIA certolizumab pegol 200 mg/ml solution for injection; CNTO 148; COSENTYX; CP; CP-690,550; CP-690,550-10; CT-P13; CTLA4Ig; Cannabidiol; Cannabidiol tablet 10 mg; Cannabis; Celebrex; Celecoxib; Celecoxib 200 milligrams; Celecoxib 400 milligrams; Celecoxib, Celebrex®; Certolizumab; Certolizumab Pegol; Certolizumab pegol; Certolizumab pegol (CZP); Certolizumab pegol / CIMZIA; Chlor; Chloride; Cimzia; Cimzia 200 mg solution for injection; Cimzia®; Cosentyx; DMARDs; DRONABINOL; Device: Technetium labelled glucosamine; Diclofenac; Diclofenac 50 milligrams; Diclofenac SR; Diclophenac; Dronabinol; Dronabinol capsule 2.5. mg; Drug treatment; E-Device; ENBREL; ENIA11; ETANERCEPT; ETORICOXIB; Enbrel; Enbrel (Etanercept); Enbrel (etanercept); Enbrel plus Celebrex; Enbrel®; Entecavir; Etanercept; Etanercept (50mg per week); Etanercept (50mg per week, for 2 weeks); Etanercept (50mg per week, for 4 weeks); Etanercept (Enbrel); Etanercept (Full-Dose); Etanercept (Half-Dose); Etoricoxib; FILGOTINIB; Fengshigutong Capsule; Fengshigutong Capsule plus Imrecoxib; Filgotinib; Focetria (Monovalent MF59-Adjuvanted vaccine); GLPG0634; GOLIMUMAB; GP2017; GP2017 (adalimumab biosimilar); Glucosamine; Gold; Golimumab; Golimumab (CNTO 148); Golimumab Injection; Golimumab Liquid in Vial; Golimumab Pre-Filled Syringe; Herpes Zoster Vaccine; Human Anti-TNF IgG1 Monoclonal Antibody; Human Anti-TNFalfa; Human anti-TNFa monoclonal antibody; Human umbilical cord-derived MSCs; Humira; Humira 40 mg/0.8 ml solution for injection; Humira®; Hydroxychloroquine; Hyrimoz; IBI303; INFLIXIMAB; INTERLEUKIN 2; IXEKIZUMAB; Ibuprofen; Iguratimod; Ilumetri; Imrecoxib; Indomethacin; Infliximab; Infliximab (BCD-055); Infliximab (Remicade); Infliximab and MTX; Interleukin 2; Intravenous infusion of MSCs; Ixekizumab; Jaktinib Hydrochloride Tablets; KIN-1901; Kunxian capsule; L04AA24; L04AB01; L04AB04; L04AB05; LSD; LY2439821; Leflunomide; Loxoprofen; Loxoprofen sodium hydrogel patch; Loxoprofen sodium tablet; Lyophilized etanercept powder(Yisaipu); METHOTREXATE; MK-0663; MK-3222; MSC; MTX; MabThera; MabThera 500; Meloxicam; Meloxicam suppository; Meloxicam tablet; Methotrexate; Methylprednisolone; Misoprostol; Monoclonal Antibody (MAb); Méthotrexate; Méthotrexate Bellon Comprimé; N.A.; NAPROXEN; NSAIDs; NSAIDs and sulfasalazine; Nanocurcumin; Naprosyn; Naprosysn; Naproxen; Naproxen 500 mg tablets (PN 200 minus omeprazole); Non-anti-TNF biologics; None; NsNSAIDs; Null; Observational study; Olsalazine; Omeprazole; Oral; Orencia; Originator; Originator (legacy) drug; Other COX-2 inhibitor; Other Cox-2 inhibitors; Other Non-selective NSAIDs; Other: 0.9ml sodium chloride; Other: No anti-inflammatory treatment; Other: general population; PN 200 tablets (500 mg naproxen and 20 mg omeprazole); Pamidronate; Parecoxib; Part I - etoricoxib 60 mg; Part I - etoricoxib 90 mg; Part I- naproxen 1000 mg; Part II- etoricoxib 60 mg; Part II- etoricoxib 90 mg; Part II- naproxen 1000 mg; Placebo; Prednisolone; Prefilled liquid etanercept(Yisaipu); Procedure: Blood sampling from infant; Procedure: Blood sampling from mother; Procedure: Blood sampling from umbilical cord; Procedure: Breast milk sampling; Propanoic acid; REMICADE; REMICADE 100 mg polvo para concentrado para solución para perfusión; REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO; ROACTEMRA 20 mg/ml, concentrado para solución para perfusión; RTNV148B IgG; Rebamipide; Recombinant TNF-a receptor: IgG Fc fusion protein; Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class; Remicade; Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remicade®; Remsima; Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; RhuTNFR:Fc; Risankizumab; Rituximab; Rituximab/ Mabthera; Ro 487-533/F01; Ro 487-5733/F01; Ro 487-7533/F01; Ro45-2294; RoActemra; RoActemra®; Rosuvastatin; SAR153191; SB4; SB4 (etanercept biosimilar); SB5; SECUKINUMAB; SHR0302; SSZ; SUNPG1622 I dose; Salazopyrin; Salazopyrin EN; Salazopyrin EN-Tabs; Salazopyrin En-Tabs; Salicylazosulfapyridine; Sarilumab; Secukinumab; Secukinumab (150 mg); Secukinumab (75 mg); Secukinumab (AIN457) 150 mg s.c.; Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.; Secukinumab 150 mg/1 ml Solution for injection; Secukinumab 150 milligram [Cosentyx]; Secukinumab 75 mg/0.5 ml Solution for injection; Simponi; Simponi®; Sodium chloride; Standard of Care; Stelara; Sulfasalazine; Sulfasalazine, SSZ; Sulphasalazine; Sulphasalazine (SSZ); Sulphasalazine 500 mg En-Tabs; Systemic non-biological treatments; TA-650 (Infliximab); THA; TNF alpha; TNF blockers (infliximab, adalimumab, etanercept); TNF-a antagonists, non-TNFs, DMARD non-biologics; TNF-alpha antagonists; TNF-inhibition; TNFR:Fc; TNR-001; TNR-001, TNFR:FC; TOCILIZUMAB; TOFACITINIB CITRATE; Taltz; Taltz (80 mg solution for injection in pre-filled syringe); Tapering or discontinuation of etanercept; Thalidomide; Thalidomide 100mg; Thalidomide 150mg; Tildrakizumab; Tildrakizumab 100 mg (one 1-mL injection of 100 mg/mL; Tildrakizumab 100 mg/ml; Tildrakizumab 200 mg (two 1-mL injections of 100 mg/mL); Tocilizumab; Tofacitinib; Tofacitinib 10 mg; Tofacitinib 2 mg; Tofacitinib 5 mg; Total Glucosides Paeony Capsules; Tramadol; Tramadol /acetaminophen; Tripterygium; Tripterygium Wilfordii; UCB4940; UPADACITINIB; Ultracet; Upadacitinib; Ustekinumab; Vessel; Voltaren resinat; Xeljanz; Yisaipu®; [18F]Fluoride

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04483700 (ClinicalTrials.gov)	December 2020	20/7/2020	Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy	Ankylosing Spondylitis	Drug: Filgotinib;Drug: Placebo to Match Filgotinib	Gilead Sciences	Galapagos NV	Not yet recruiting	18 Years	N/A	All	408	Phase 3	NULL
2	NCT04483687 (ClinicalTrials.gov)	December 2020	20/7/2020	Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy	Ankylosing Spondylitis	Drug: Filgotinib;Drug: Placebo to Match Filgotinib	Gilead Sciences	Galapagos NV	Not yet recruiting	18 Years	N/A	All	576	Phase 3	NULL
3	EUCTR2018-003933-14-BE (EUCTR)	19/07/2019	24/04/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Galapagos NV	NULL	Not Recruiting			Female: no Male: yes	250	Phase 2	Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
4	EUCTR2018-003933-14-BG (EUCTR)	21/06/2019	27/03/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Estonia;Czech Republic;Spain;Poland;Ukraine;Bulgaria;Latvia
5	NCT03926195 (ClinicalTrials.gov)	May 28, 2019	19/4/2019	Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis	Rheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Non-Radiographical Axial Spondyloarthritis	Drug: Filgotinib;Drug: Placebo;Drug: Standard of Care	Galapagos NV	Gilead Sciences	Active, not recruiting	21 Years	65 Years	Male	109	Phase 2	Belgium;Bosnia and Herzegovina;Bulgaria;Czechia;Estonia;Georgia;Latvia;Poland;Spain;Ukraine
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2018-003933-14-CZ (EUCTR)	28/05/2019	29/04/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of
7	EUCTR2018-003933-14-LV (EUCTR)	27/05/2019	07/03/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Latvia;Germany;Moldova, Republic of
8	EUCTR2018-003933-14-ES (EUCTR)	30/04/2019	21/05/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
9	EUCTR2018-003933-14-EE (EUCTR)	09/04/2019	14/03/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Czech Republic;Estonia;Spain;Poland;Ukraine;Bulgaria;Latvia
10	EUCTR2016-003636-21-BE (EUCTR)	12/04/2017	13/02/2017	A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitis	A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis	ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Estonia;Czech Republic;Poland;Spain;Belgium;Ukraine;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2016-003636-21-BG (EUCTR)	11/04/2017	03/02/2017	A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitis	A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis	ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany
12	NCT03117270 (ClinicalTrials.gov)	March 7, 2017	30/3/2017	A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 12 Weeks to Subjects With Active Ankylosing Spondylitis	Ankylosing Spondylitis	Drug: filgotinib;Drug: Placebo Oral Tablet	Galapagos NV	NULL	Completed	18 Years	N/A	All	116	Phase 2	Belgium;Bulgaria;Czechia;Estonia;Poland;Spain;Ukraine
13	EUCTR2016-003636-21-CZ (EUCTR)	14/02/2017	19/12/2016	A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitis	A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis	ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany
14	EUCTR2016-003636-21-ES (EUCTR)	01/02/2017	22/12/2016	A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitis	A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis	ankylosing spondylitis MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany
15	EUCTR2016-003636-21-EE (EUCTR)	26/01/2017	08/12/2016	A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitis	A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis	ankylosing spondylitis MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 2	Czech Republic;Estonia;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04483700
(ClinicalTrials.gov)

December 2020

20/7/2020

Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy

Ankylosing Spondylitis

Drug: Filgotinib;Drug: Placebo to Match Filgotinib

Gilead Sciences

Galapagos NV

Not yet recruiting

18 Years

N/A

All

408

Phase 3

NULL

NCT04483687
(ClinicalTrials.gov)

December 2020

20/7/2020

Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy

Ankylosing Spondylitis

Drug: Filgotinib;Drug: Placebo to Match Filgotinib

Gilead Sciences

Galapagos NV

Not yet recruiting

18 Years

N/A

All

576

Phase 3

NULL

EUCTR2018-003933-14-BE
(EUCTR)

19/07/2019

24/04/2019

A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB

Galapagos NV

NULL

Not Recruiting

Female: no
Male: yes

250

Phase 2

Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina

EUCTR2018-003933-14-BG
(EUCTR)

21/06/2019

27/03/2019

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Estonia;Czech Republic;Spain;Poland;Ukraine;Bulgaria;Latvia

NCT03926195
(ClinicalTrials.gov)

May 28, 2019

19/4/2019

Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis

Rheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Non-Radiographical Axial Spondyloarthritis

Drug: Filgotinib;Drug: Placebo;Drug: Standard of Care

Galapagos NV

Gilead Sciences

Active, not recruiting

21 Years

65 Years

Male

109

Phase 2

Belgium;Bosnia and Herzegovina;Bulgaria;Czechia;Estonia;Georgia;Latvia;Poland;Spain;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-003933-14-CZ
(EUCTR)

28/05/2019

29/04/2019

Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of

EUCTR2018-003933-14-LV
(EUCTR)

27/05/2019

07/03/2019

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Latvia;Germany;Moldova, Republic of

EUCTR2018-003933-14-ES
(EUCTR)

30/04/2019

21/05/2019

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina

EUCTR2018-003933-14-EE
(EUCTR)

09/04/2019

14/03/2019

Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Czech Republic;Estonia;Spain;Poland;Ukraine;Bulgaria;Latvia

EUCTR2016-003636-21-BE
(EUCTR)

12/04/2017

13/02/2017

A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitis

A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis

ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Estonia;Czech Republic;Poland;Spain;Belgium;Ukraine;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-003636-21-BG
(EUCTR)

11/04/2017

03/02/2017

A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitis

A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis

Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany

NCT03117270
(ClinicalTrials.gov)

March 7, 2017

30/3/2017

A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 12 Weeks to Subjects With Active Ankylosing Spondylitis

Ankylosing Spondylitis

Drug: filgotinib;Drug: Placebo Oral Tablet

Galapagos NV

NULL

Completed

18 Years

N/A

All

116

Phase 2

Belgium;Bulgaria;Czechia;Estonia;Poland;Spain;Ukraine

EUCTR2016-003636-21-CZ
(EUCTR)

14/02/2017

19/12/2016

A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitis

A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis

ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany

EUCTR2016-003636-21-ES
(EUCTR)

01/02/2017

22/12/2016

A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitis

A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis

ankylosing spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany

EUCTR2016-003636-21-EE
(EUCTR)

26/01/2017

08/12/2016

A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitis

A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis

Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2

Czech Republic;Estonia;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany