Back to discover
Disease
Myositis
Late-stage therapeutic developmentEmerging research
4
Publications
19
Clinical trials
2024
Latest publication
Latest activity
betaRecent clinical, regulatory, research and industry developments relating to this disease.
Research2024-09-07Molecular therapy : the journal of the American Society of Gene Therapy
CD19 CAR T-Cell Therapy in Autoimmune Disease - A Case Series with Follow-up.
Research2024-02-01The New England journal of medicine
Research2024-01-01Rheumatology (Oxford, England)
Research2023-12-23Journal of neurology
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
Executive briefingUpdating summary…Momentum: Moderate
Key developments
- 4 clinical trials expected to report results, the earliest in Q4 2026.
Upcoming Milestones
- Q4 2026A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart in Adults With Dermatomyositis
- Q3 2027A PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS)
- Q4 2027A Double-Blind Randomised Controlled Trial (dbRCT) Phase III Trial Investigating the Effect of Sirolimus on Disease Progression in Patients With Inclusion Body Myositis (IBM) as Measured by the IBM Functional Rating Scale (IBM-FRS)
- Q3 2028A Phase 2-Phase 3, Double-blinded, Randomized, Dose-repeating, Cross-over Study to Assess the Safety and Efficacy of Allogeneic ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM)
Major developments
Upcoming trial readoutHigh impact
Results expected Q3 20272026-06-01
Upcoming trial readoutHigh impact
Results expected Q3 20282026-04-27
Clinical MilestonesViewHide
Results expected
- 2026-06-01A PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS)Results expected Q3 2027
- 2026-04-27A Phase 2-Phase 3, Double-blinded, Randomized, Dose-repeating, Cross-over Study to Assess the Safety and Efficacy of Allogeneic ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM)Results expected Q3 2028
- 2026-01-14A Double-Blind Randomised Controlled Trial (dbRCT) Phase III Trial Investigating the Effect of Sirolimus on Disease Progression in Patients With Inclusion Body Myositis (IBM) as Measured by the IBM Functional Rating Scale (IBM-FRS)Results expected Q4 2027
- 2025-09-25A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart in Adults With DermatomyositisResults expected Q4 2026
Recently completed
- 2025-12-31Nintedanib Plus Standard of Care Immunosuppression Versus Standard of Care Immunosuppression Alone in Patients With Progressive Fibrotic Myositis Associated - Interstitial Lung Disease: A Randomized, Double-Blind, Exploratory TrialCompleted
- 2025-11-27A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABC008 in the Treatment of Subjects With Inclusion Body MyositisCompleted
- 2025-09-25Treatment With add-on IVIg in Myositis Early In the diSease Course May be sUperior to Steroids Alone for Reaching CLinical improvemEntPrimary completion
Other updates
Activity timeline8
- 2026-06-01ClinicalA PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS)Results expected Q3 2027
- 2026-04-27ClinicalA Phase 2-Phase 3, Double-blinded, Randomized, Dose-repeating, Cross-over Study to Assess the Safety and Efficacy of Allogeneic ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM)Results expected Q3 2028
- 2026-01-14ClinicalA Double-Blind Randomised Controlled Trial (dbRCT) Phase III Trial Investigating the Effect of Sirolimus on Disease Progression in Patients With Inclusion Body Myositis (IBM) as Measured by the IBM Functional Rating Scale (IBM-FRS)Results expected Q4 2027
- 2025-12-31ClinicalNintedanib Plus Standard of Care Immunosuppression Versus Standard of Care Immunosuppression Alone in Patients With Progressive Fibrotic Myositis Associated - Interstitial Lung Disease: A Randomized, Double-Blind, Exploratory TrialCompleted
- 2025-11-27ClinicalA Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABC008 in the Treatment of Subjects With Inclusion Body MyositisCompleted
- 2025-11-21ClinicalA Phase II Open-Label Study of Deucravacitinib for Refractory Adults With Dermatomyositis/ Juvenile DermatomyositisWithdrawn
- 2025-09-25ClinicalA Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart in Adults With DermatomyositisResults expected Q4 2026
- 2025-09-25ClinicalTreatment With add-on IVIg in Myositis Early In the diSease Course May be sUperior to Steroids Alone for Reaching CLinical improvemEntPrimary completion
Clinical trials
The current development programme across all trial phases.
Clinical programme
19
6
12
6
Late-stage studies
Recruiting
Recently completed
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Most influential
Recent publications
Major themes8
- Myositis4
- Antigens, CD192
- Immunotherapy, Adoptive2
- Antineoplastic Agents, Immunological1
- Lupus Erythematosus, Systemic1
- Myeloablative Agonists1
- Myocarditis1
- Receptors, Antigen, T-Cell1
Leading journals4
- Journal of neurology1
- Molecular therapy : the journal of the American Society of Gene Therapy1
- Rheumatology (Oxford, England)1
- The New England journal of medicine1
Leading researchers8
- Aigner M2
- Knitza J2
- Kretschmann S2
- Mackensen A2
- Müller F2
- Schett G2
- Taubmann J2
- Völkl S2
Affiliations (unnormalised)6
- and the Institute of Clinical Microbiology1
- Department of Clinical Neurosciences1
- Friedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen1
- Institute of Radiology1
- Lausanne University Hospital and University of Lausanne1
- Lundin Family Brain Tumor Center1
Reference
Authoritative identity, definition & identifiers.
Defined in MeSH
Inflammation of a muscle or muscle tissue.
Identifiers
References & data sources
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.