DDrare: Database of Drug Development for Rare Diseases

50. 皮膚筋炎／多発性筋炎
［臨床試験数：157，薬物数：207（DrugBank：76），標的遺伝子数：47，標的パスウェイ数：142］

Searched query = "Dermatomyositis", "Polymyositis"
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 = 0.9% w/v isotonic sodium chloride solution; 10% nifedipine cream; 3 MPDN pulse + PDN; 3 MPDN pulse + PDN + CSA; 3 MPDN pulse + PDN + MTX; 35mg; 44/154/85-C; 44/196/81-C; 5% sildenafil cream; 56/104/75-C; 5mg; ABATACEPT; ALFACALCIDOL; Abatacept; Abatacept Active Treatment; Abatacept Delayed-Onset Treatment; Abatacept subcutaneous; Acthar; Acthar Gel; Adrenocorticotropic Hormone Gel; Adrenocorticotropic hormone; Ajulemic acid; Alendronate; Alendronate versus alfacalcidol (1-alpha OH vitamin D); Alfacalcidol; Alfacalcidol 2 micrograms/ml; Anakinra; Anti-pandemic H1N1 influenza vaccine; Apremilast; Apremilast 30mg; BAF312; BAF312 0,5 mg tablet; BAF312 0.25 mg; BAF312 0.25 mg tablet; BAF312 0.25mg tablet; BAF312 0.5 mg; BAF312 0.50 mg; BAF312 1 mg; BAF312 1 mg tablet; BAF312 1mg; BAF312 1mg tablet; BAF312 2 mg; BAF312 2 mg tablet; BAF312 2mg; BAF312 4mg tablet; BAF312 5 mg tablet; BAF312 hemifumarate; BAF312X; BARICITINIB; Baricitinib; Basiliximab; Calcineurin Inhibitors; Carbon; Carbon dioxide; Cervarix; Cervarix suspensie voor injectie; Chloride; Ciclosporin; Creapure; Creatine; CsA; CyA; Cyclophosphamide; Cyclophosphamide Injection 1g; Cyclosporin; Cyclosporine; Cyclosporine A; Denosumab; Device: Fractionated Carbon Dioxide (FCO2) Laser; Drops; EMEA/H/C/000701; Etanercept; GB-0998; Gamma Globulin; Gevokizumab; Glucose; Glucose Tablet; Gold; Grapefruit; H.P. Acthar Gel; H5G1.1-mAb; HBVAXPRO; HBvaxpro; HUMAN NORMAL IMMUNOGLOBULIN; Hbvaxpro; Hizentra; Human Normal Immunoglobulin; Human immunoglobulin G; Human normal immunoglobulin; Human normal immunoglobulin (IVIg); Human normal immunoglogulin (IVIg); IFN-K; IFN-Kinoid; IFN-Kinoid Drug Substance; IFNa-Kinoid; IGVENA*FL 200ML 10G+SET; IMMUNOGLOBULIN G; IMO-8400; IMO-8400 Dose Group 1; IMO-8400 Dose Group 2; IVIg; Ig VENA; Ig VENA (10g/200mL); Ig Vena; IgPro20; Immunoglobulin (Hizentra); Immunosuppressive Agents; Impact; Infliximab; Influvac; Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung; JBT-101; KZR-616; KZR-616 maleate; L0133; LY3009104; Lenabasum; Lenabasum 20 mg; Lenabasum 5 mg; Lipid-lowering agents (Artovastatin); MEDI-545; MEDI7734; METHOTREXATE; MMF; MTX; MabThera; Mabthera; Methimazole; Methotrexat; Methotrexat Lachema 2,5mg; Methotrexat Lachema 2,5mg tbl.; Methotrexat Lachema 5 inj. sol; Methotrexate; Methotrexate Lachema 5inj. sol; Methotrexate Wyeth 2,5mg; Methotrexate Wyeth 2,5mg tbl.; Methylprednisolone; Methylprednisolone sodium succinate; Methylprednisoloni natrii succinas; Metoject 10 mg/ml; Metotrexat; Metotrexate; Nifedipine; Nivolumab; ORENCIA; Octagam 10%; Octanorm; Octanorm 16.5%; One Alpha; One Alpha Drops; One-Alpha drops; One-alpha; Orencia; Orencia (trade name); Other: ISA 51; PF-06823859 high; PF-06823859 low; PREDNISON 5, 20 Léciva por. tablet nob; Pirfenidone; Placebo; Placebo IV; Placebo SC; Pneumovax 23; Prednisolon; Prednisolon Pfizer; Prednisolone; Prednison 5, 20 Léciva por. tablet nob.; Prednisone; RISEDRONATE SODIUM; Resunab, ajulemic acid, anabasum; Risedronate; Risedronate Sodium; Rituximab; S78989; SODIUM CHLORIDE; SODIUM THIOSULFATE PENTAHYDRATE; STS; Sildenafil; Siponimid; Siponimod; Siponimod 0.25 mg tablet; Siponimod 0.5 mg tablet; Siponimod 1 mg tablet; Siponimod 2 mg Tablet; Sodium Thiosulfate; Sodium Thiosulfate 10%; Sodium chloride; Sodium thiosulfate; Sodium thiosulfate 10%; Solu-Medrol; Solu-medrol; Solu-medrol inj. PSO LQF 40mg; Solu-medrol inj. PSO lqf 40mg; Steroids; Tacrolimus; Tocilizumab; Tofacitinib; Tofacitinib 5 MG [Xeljanz]; Treatment defined only by active substance; Ustekinumab; Ustekinumab 6 mg/kg; Ustekinumab 90 mg; VIB7734; Vitamin D; XOMA 052; Yellow Fever Vaccine; Yellow Fever vaccine (17D)

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	JPRN-JapicCTI-194822	27/8/2019	25/06/2019	A Study of Ustekinumab in Participants with Active Polymyositis and Dermatomyositis who Have not Adequately Responded to one or More Standard-of-care Treatments	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments	PolymyositisDermatomyositis	Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the intervention : Group 1: Ustekinumab + Placebo Group 2: Placebo + Ustekinumab Participants will receive body weight-range based IV dosing of 6 mg/kg of ustekinumab at Week 0 in Group 1 and at Week 24 in Group 2. Control intervention name : placebo IV INN of the control intervention : - Dosage And administration of the control intervention : Group 1: Ustekinumab + Placebo Group 2: Placebo + Ustekinumab Participants will receive IV dosing of placebo at Week 24 in Group 1 and at Week 0 in Group 2. Control intervention name : Placebo SC INN of the control intervention : - Dosage And administration of the control intervention : Group 2: Placebo + Ustekinumab Participants will receive SC dosing of placebo at Weeks 8,16 and 24.	Janssen Pharmaceutical K.K.	NULL	recruiting	18	75	BOTH	50	Phase 3	Japan
2	NCT03981744 (ClinicalTrials.gov)	July 26, 2019	7/6/2019	A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments	Polymyositis;Dermatomyositis	Drug: Ustekinumab 6 mg/kg;Drug: Ustekinumab 90 mg;Drug: Placebo IV;Drug: Placebo SC	Janssen Pharmaceutical K.K.	NULL	Recruiting	18 Years	75 Years	All	50	Phase 3	Japan

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

JPRN-JapicCTI-194822

27/8/2019

25/06/2019

A Study of Ustekinumab in Participants with Active Polymyositis and Dermatomyositis who Have not Adequately Responded to one or More Standard-of-care Treatments

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments

PolymyositisDermatomyositis

Intervention name : Ustekinumab
INN of the intervention : Ustekinumab
Dosage And administration of the intervention : Group 1: Ustekinumab + Placebo Group 2: Placebo + Ustekinumab Participants will receive body weight-range based IV dosing of 6 mg/kg of ustekinumab at Week 0 in Group 1 and at Week 24 in Group 2.
Control intervention name : placebo IV
INN of the control intervention : -
Dosage And administration of the control intervention : Group 1: Ustekinumab + Placebo Group 2: Placebo + Ustekinumab Participants will receive IV dosing of placebo at Week 24 in Group 1 and at Week 0 in Group 2.
Control intervention name : Placebo SC
INN of the control intervention : -
Dosage And administration of the control intervention : Group 2: Placebo + Ustekinumab Participants will receive SC dosing of placebo at Weeks 8,16 and 24.

Janssen Pharmaceutical K.K.

NULL

recruiting

BOTH

Phase 3

Japan

NCT03981744
(ClinicalTrials.gov)

July 26, 2019

7/6/2019

A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments

Polymyositis;Dermatomyositis

Drug: Ustekinumab 6 mg/kg;Drug: Ustekinumab 90 mg;Drug: Placebo IV;Drug: Placebo SC

Janssen Pharmaceutical K.K.

NULL

Recruiting

18 Years

75 Years

All

Phase 3

Japan