Clinical trials: Myositis
Polymyositis, Dermatomyositis
Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
This study determined the efficacy, safety, tolerability and the PK profile of BAF312, a novel immunomodulator, in polymyositis and dermatomyositis patients who were not responsive to traditional immunosuppressive and/or…
- Trial name
- NCT01148810
- Testing
- BAF312
- Where
- 6 sites in United States, Czechia and 3 more
- Volunteers
- 18 people
- Sponsor
- Novartis Pharmaceuticals
Fibrodysplasia Ossificans Progressiva
An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects
Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and…
- Trial name
- NCT02190747
- Testing
- Palovarotene
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 40 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Dermatomyositis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM).
- Trial name
- RECLAIIM (NCT04044690)
- Testing
- human immunoglobulin G
- Where
- 76 sites in United States, Argentina and 12 more
- Volunteers
- 134 people
- Sponsor
- CSL Behring
Polymyositis, Dermatomyositis
A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis
This was a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of treatment with KZR-616 in patients…
- Trial name
- PRESIDIO (NCT04033926)
- Testing
- KZR-616
- Where
- 14 sites in United States, Czechia and 1 more
- Volunteers
- 25 people
- Sponsor
- Kezar Life Sciences, Inc.
Dermatomyositis
Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine.
- Trial name
- NCT02466243
- Testing
- JBT-101
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Corbus Pharmaceuticals Inc.
Fibrodysplasia Ossificans Progressiva (FOP)
A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.
The main objective of this study is to further evaluate the safety and efficacy of palovarotene in adult and paediatric participants with FOP.
- Trial name
- PIVOINE (NCT05027802)
- Testing
- Palovarotene
- Where
- 13 sites in United States, Argentina and 8 more
- Volunteers
- 61 people
- Sponsor
- Ipsen
Active Dermatomyositis
Safety and Efficacy of BAF312 in Dermatomyositis
This study investigated the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal…
- Trial name
- NCT02029274
- Testing
- BAF312
- Where
- 9 sites in United States, Czechia and 1 more
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Fibrodysplasia Ossificans Progressiva
A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva
This is a three period study design consisting of a 6-month, randomized, double-blind placebo-controlled treatment (period 1) followed by a 6-month, open-label treatment (period 2) and a follow-up treatment period (period 3).
- Trial name
- LUMINA-1 (NCT03188666)
- Testing
- REGN2477
- Where
- 11 sites in United States, Canada and 6 more
- Volunteers
- 44 people
- Sponsor
- Regeneron Pharmaceuticals
Dermatomyositis
Trial of IMO-8400 in Adult Patients With Dermatomyositis
The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis.
- Trial name
- 8400-211 (NCT02612857)
- Testing
- IMO-8400 Dose Group 1, IMO-8400 Dose Group 2
- Where
- 20 sites in United States, Hungary and 1 more
- Volunteers
- 30 people
- Sponsor
- Idera Pharmaceuticals, Inc.
Sporadic Inclusion Body Myositis (sIBM)
Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
This study is an open-label, long-term study for those patients who participated in the prior proof-of-concept protocol, in which the preliminary efficacy for BYM338 in patients with sIBM was demonstrated after a single 30 mg/kg…
- Trial name
- BYM338 (NCT02250443)
- Testing
- BYM338 (Bimagrumab)
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Polymyositis
Efficacy and Tolerability of BAF312 in Patients With Polymyositis
This study assessed the efficacy, safety and tolerability of BAF312 administered orally in patients with clinically active polymyositis and also in patients with polymyositis who had shown inadequate response to corticosteroids…
- Trial name
- NCT01801917
- Testing
- BAF312
- Where
- 8 sites in United States, Canada and 4 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
Dermatomyositis
An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study
The purpose of this research study is to evaluate the long-term safety, and tolerability of PF-06823859 study drug in adult participants with Dermatomyositis (DM) from a qualifying study.
- Trial name
- NCT05192200
- Testing
- Anti-Beta Interferon (PF-06823859)
- Where
- 25 sites in United States, Hungary and 2 more
- Volunteers
- 24 people
- Sponsor
- Pfizer
Dermatomyositis
Study Evaluating Efficacy and Safety of Octanorm in Patients With Dermatomyositis
DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS
- Trial name
- NCT03686969
- Testing
- Octanorm
- Where
- Russia
- Volunteers
- 1 people
- Sponsor
- Octapharma
Dermatomyositis
Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis
This is a Phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants…
- Trial name
- NCT04999020
- Testing
- Ravulizumab
- Where
- 111 sites in United States, Australia and 11 more
- Volunteers
- 38 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Inclusion Body Myositis
Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension Trial
A multicenter, nonrandomized, open-label, uncontrolled clinical extension trial designed to compare the efficacy and safety of early versus delayed start of arimoclomol in the treatment of Inclusion Body Myositis (IBM)
- Trial name
- NCT04049097
- Testing
- Arimoclomol
- Where
- 12 sites in United States, United Kingdom
- Volunteers
- 121 people
- Sponsor
- ZevraDenmark
Inclusion Body Myositis
Study of Arimoclomol in Inclusion Body Myositis (IBM)
Funding Source - FDA Office of Orphan Products Development (OOPD). The purpose of this study is to evaluate the safety and efficacy of the study drug, arimoclomol in IBM patients.
- Trial name
- NCT02753530
- Testing
- Arimoclomol
- Where
- 12 sites in United States, United Kingdom
- Volunteers
- 152 people
- Sponsor
- ZevraDenmark
Fibrodysplasia Ossificans Progressiva
In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation (heterotopic ossification…
- Trial name
- NCT02521792
- Testing
- Palovarotene
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Dermatomyositis
Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")
- Trial name
- IIM (NCT02728752)
- Testing
- Octagam 10%
- Where
- 37 sites in United States, Canada and 8 more
- Volunteers
- 95 people
- Sponsor
- Octapharma
Inclusion Body Myositis
A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis
- Trial name
- NCT05721573
- Testing
- ABC008
- Where
- 45 sites in United States, Australia and 5 more
- Volunteers
- 272 people
- Sponsor
- Abcuro, Inc.
Fibrodysplasia Ossificans Progressiva
An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue…
- Trial name
- NCT02279095
- Testing
- Palovarotene dose level 1, Palovarotene dose level 2, Palovarotene dose level 3
- Where
- 8 sites in United States, Argentina and 3 more
- Volunteers
- 58 people
- Sponsor
- Clementia Pharmaceuticals Inc.