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	EUCTR2012-005772-34-BE (EUCTR)	03/12/2014	13/10/2014	A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease.	A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease	Polymyositis / Dermatomyositis / necrotizing autoimmune myopathy MedDRA version: 17.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052	Institut de Recherches Internationales Servier (IRIS)	NULL	Not Recruiting			Female: yes Male: yes	40		Greece;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Denmark;South Africa;Germany;Sweden
2	EUCTR2012-005772-34-GR (EUCTR)	11/11/2014	20/10/2014	A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease	A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease	Polymyositis / Dermatomyositis MedDRA version: 17.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.0;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052	Institut de Recherches Internationales Servier (IRIS)	NULL	Not Recruiting			Female: yes Male: yes	40		Greece;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Brazil;Australia;Denmark;South Africa;Germany;Sweden
3	EUCTR2012-005772-34-GB (EUCTR)	21/01/2014	10/06/2013	A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis or necrotizing autoimmune myopathy disease	A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis or dermatomyositis or necrotizing autoimmune myopathy disease	Polymyositis / Dermatomyositis / Necrotizing autoimmune myopathy MedDRA version: 17.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052	Servier Research and Development Ltd.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;Hungary;Czech Republic;Greece;Belgium;Brazil;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
4	EUCTR2012-005772-34-DE (EUCTR)	09/09/2013	04/06/2013	A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease	A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease	Polymyositis / Dermatomyositis/ necrotizing autoimmune myopathy MedDRA version: 17.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052	Institut de Recherches Internationales Servier (IRIS)	NULL	Not Recruiting			Female: yes Male: yes	40		France;Hungary;Czech Republic;Belgium;Brazil;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
5	EUCTR2012-005772-34-SE (EUCTR)	04/09/2013	03/06/2013	A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease.	A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease	Polymyositis / Dermatomyositis / necrotizing autoimmune myopathy MedDRA version: 17.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052	Institut de Recherches Internationales Servier (IRIS)	NULL	Not Recruiting			Female: yes Male: yes	40		Greece;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Denmark;South Africa;Germany;Sweden
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	EUCTR2012-005772-34-HU (EUCTR)	11/07/2013	12/06/2013	A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis , dermatomyositis or necrotizing autoimmune myophaty disease	A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myophaty disease	Polymyositis / Dermatomyositis /necrotizing autoimmune myophaty MedDRA version: 17.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052	Institut de Recherches Internationales Servier (IRIS)	NULL	Not Recruiting			Female: yes Male: yes	40		France;Czech Republic;Hungary;Belgium;Spain;Brazil;Denmark;Germany;United Kingdom;Italy;Sweden
7	EUCTR2012-005772-34-ES (EUCTR)	24/06/2013	10/06/2013	A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease	A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease	Polymyositis / Dermatomyositis MedDRA version: 16.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 16.0;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052	Laboratorios Servier S.L	Institut de Recherches Internationales Servier (IRIS)	Not Recruiting			Female: yes Male: yes	40		Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Argentina;Brazil;Belgium;Denmark;Norway;Germany;Sweden
8	EUCTR2012-005772-34-IT (EUCTR)	17/06/2013	22/05/2013	A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease	A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease	Polymyositis / Dermatomyositis MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052	Institut de Recherches Internationales Servier (IRIS)	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Greece;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Argentina;Brazil;Belgium;Denmark;Norway;Germany;Sweden
9	EUCTR2012-005772-34-CZ (EUCTR)	06/06/2013	06/06/2013	A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease	A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease	Polymyositis / Dermatomyositis / necrotizing autoimmune myopathy MedDRA version: 18.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 18.0;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052	Institut de Recherches Internationales Servier (IRIS)	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;Hungary;Czech Republic;Greece;Belgium;Spain;Brazil;Denmark;Germany;United Kingdom;Italy;Sweden

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

EUCTR2012-005772-34-BE
(EUCTR)

03/12/2014

13/10/2014

A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease.

A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease

Polymyositis / Dermatomyositis / necrotizing autoimmune myopathy
MedDRA version: 17.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052

Institut de Recherches Internationales Servier (IRIS)

NULL

Not Recruiting

Female: yes
Male: yes

Greece;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Denmark;South Africa;Germany;Sweden

EUCTR2012-005772-34-GR
(EUCTR)

11/11/2014

20/10/2014

A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease

Polymyositis / Dermatomyositis
MedDRA version: 17.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.0;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052

Institut de Recherches Internationales Servier (IRIS)

NULL

Not Recruiting

Female: yes
Male: yes

Greece;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Brazil;Australia;Denmark;South Africa;Germany;Sweden

EUCTR2012-005772-34-GB
(EUCTR)

21/01/2014

10/06/2013

A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis or necrotizing autoimmune myopathy disease

A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis or dermatomyositis or necrotizing autoimmune myopathy disease

Polymyositis / Dermatomyositis / Necrotizing autoimmune myopathy
MedDRA version: 17.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052

Servier Research and Development Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Czech Republic;Greece;Belgium;Brazil;Spain;Denmark;Germany;Italy;United Kingdom;Sweden

EUCTR2012-005772-34-DE
(EUCTR)

09/09/2013

04/06/2013

Polymyositis / Dermatomyositis/ necrotizing autoimmune myopathy
MedDRA version: 17.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052

Institut de Recherches Internationales Servier (IRIS)

NULL

Not Recruiting

Female: yes
Male: yes

France;Hungary;Czech Republic;Belgium;Brazil;Spain;Denmark;Germany;Italy;United Kingdom;Sweden

EUCTR2012-005772-34-SE
(EUCTR)

04/09/2013

03/06/2013

Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052

Institut de Recherches Internationales Servier (IRIS)

NULL

Not Recruiting

Female: yes
Male: yes

Greece;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Denmark;South Africa;Germany;Sweden

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

EUCTR2012-005772-34-HU
(EUCTR)

11/07/2013

12/06/2013

A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis , dermatomyositis or necrotizing autoimmune myophaty disease

Polymyositis / Dermatomyositis /necrotizing autoimmune myophaty
MedDRA version: 17.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052

Institut de Recherches Internationales Servier (IRIS)

NULL

Not Recruiting

Female: yes
Male: yes

France;Czech Republic;Hungary;Belgium;Spain;Brazil;Denmark;Germany;United Kingdom;Italy;Sweden

EUCTR2012-005772-34-ES
(EUCTR)

24/06/2013

10/06/2013

A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease

Polymyositis / Dermatomyositis
MedDRA version: 16.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 16.0;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052

Laboratorios Servier S.L

Institut de Recherches Internationales Servier (IRIS)

Not Recruiting

Female: yes
Male: yes

Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Argentina;Brazil;Belgium;Denmark;Norway;Germany;Sweden

EUCTR2012-005772-34-IT
(EUCTR)

17/06/2013

22/05/2013

A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease

Polymyositis / Dermatomyositis
MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052

Institut de Recherches Internationales Servier (IRIS)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Greece;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Argentina;Brazil;Belgium;Denmark;Norway;Germany;Sweden

EUCTR2012-005772-34-CZ
(EUCTR)

06/06/2013

Polymyositis / Dermatomyositis / necrotizing autoimmune myopathy
MedDRA version: 18.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 18.0;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052

Institut de Recherches Internationales Servier (IRIS)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Czech Republic;Greece;Belgium;Spain;Brazil;Denmark;Germany;United Kingdom;Italy;Sweden