DDrare: Database of Drug Development for Rare Diseases

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	EUCTR2018-003171-35-DE (EUCTR)	20/01/2020	18/09/2019	A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study	Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra	CSL Behring LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	126	Phase 3	United States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;European Union;Mexico;Argentina;Australia;Germany;Japan
2	EUCTR2018-003171-35-ES (EUCTR)	14/11/2019	29/11/2019	A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM)	Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		CSL Behring LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	126	Phase 3	United States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;European Union;Mexico;Canada;Argentina;Australia;Germany;Japan
3	NCT04044690 (ClinicalTrials.gov)	October 21, 2019	1/8/2019	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study	Dermatomyositis	Drug: human immunoglobulin G;Drug: Placebo	CSL Behring	NULL	Recruiting	18 Years	N/A	All	126	Phase 3	United States;Germany;Italy;Japan;Russian Federation;Switzerland;Ukraine
4	EUCTR2018-003171-35-FR (EUCTR)	24/09/2019	11/09/2019	A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM)	Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		CSL Behring LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	126	Phase 3	United States;France;Mexico;European Union;Canada;Argentina;Ukraine;Australia;Russian Federation;Japan;United Kingdom;Switzerland
5	NCT02271165 (ClinicalTrials.gov)	November 2014	15/10/2014	Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study		Dermatomyositis	Drug: Immunoglobulin (Hizentra)	Thomas Jefferson University	NULL	Terminated	18 Years	N/A	All	2	Early Phase 1	United States

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

EUCTR2018-003171-35-DE
(EUCTR)

20/01/2020

18/09/2019

A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study

Dermatomyositis
MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trade Name: Hizentra
Product Name: human immunoglobulin G
Product Code: IgPro20
INN or Proposed INN: human immunoglobulin G
Other descriptive name: Hizentra

CSL Behring LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

126

Phase 3

United States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;European Union;Mexico;Argentina;Australia;Germany;Japan

EUCTR2018-003171-35-ES
(EUCTR)

14/11/2019

29/11/2019

A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM)

Dermatomyositis
MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

CSL Behring LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

126

Phase 3

United States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;European Union;Mexico;Canada;Argentina;Australia;Germany;Japan

NCT04044690
(ClinicalTrials.gov)

October 21, 2019

1/8/2019

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study

Dermatomyositis

Drug: human immunoglobulin G;Drug: Placebo

CSL Behring

NULL

Recruiting

18 Years

N/A

All

126

Phase 3

United States;Germany;Italy;Japan;Russian Federation;Switzerland;Ukraine

EUCTR2018-003171-35-FR
(EUCTR)

24/09/2019

11/09/2019

A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM)

Dermatomyositis
MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

CSL Behring LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

126

Phase 3

United States;France;Mexico;European Union;Canada;Argentina;Ukraine;Australia;Russian Federation;Japan;United Kingdom;Switzerland

NCT02271165
(ClinicalTrials.gov)

November 2014

15/10/2014

Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study

Dermatomyositis

Drug: Immunoglobulin (Hizentra)

Thomas Jefferson University

NULL

Terminated

18 Years

N/A

All

Early Phase 1

United States