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Home › Conditions › Polymyositis

Polymyositis

Subtypes of Polymyositis

Dermatomyositis 3

4 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Polymyositis

8 trials tracked for Polymyositis: 3 in phase 3 or 4 and 1 with published results. The most-cited published study has 46 citations.

8Trials tracked
3Phase 3 & 4
0Recruiting
1With published results
Phase distribution
Phase 3 3 Phase 2 5
  1. Phase 3 Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus Completed · 46 cited
  2. Phase 3 Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM Completed
  3. Phase 3 Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy Completed
  4. Phase 2 A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis Completed
  5. Phase 2 Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) Completed
  6. Phase 2 Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM. Completed
Show 2 more trials
  1. Phase 2 Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis Completed
  2. Phase 2 Acthar in Treatment of Refractory Dermatomyositis and Polymyositis Completed

Showing the 8 most-cited and recently-updated of 8 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Polymyositis: what the trials found

Clinical management of polymyositis includes the use of Tacrolimus 1 and Prednisone 3. Additionally, KZR-616 has demonstrated clinical activity in patients; a Phase 2 trial reported a mean Total Improvement Score (TIS) of 36.4 at week 48 4, while another study showed mean TIS changes ranging from 25.0 to 33.5 during the treatment period, with significant reductions observed across multiple IMACS Individual CSAMs 5.

Abatacept subcutaneous administration was evaluated in a Phase 3 trial; however, the number of participants achieving the International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at week 24 without rescue did not reach statistical significance (p=0.083) 2. Regarding primary outcomes, the Myositis Response Criteria (MRC) Total Improvement Score from baseline to week 24 was recorded as 40.83 for the intervention and 37.22 for the comparator 2.

Recent results — preliminary, needs further review

  • Tocilizumab showed no statistically significant difference compared to placebo in terms of Average Total Improvement Scores (p=0.86), Time to First Definition of Improvement (p=0.77), or count of Adverse Events (p=0.40) over a 6-month period 6.
  • Adrenocorticotropic Hormone Gel demonstrated a statistically significant steroid-sparing effect in refractory adult PM and DM patients (p=<0.01) 7.
  • Rituximab showed no statistically significant difference compared to the control group regarding Time to Improvement (p=0.74) or Response Rates at week 8 (p=>0.90) in patients with Idiopathic Inflammatory Myopathy 8.

For the clinician treating this condition

  • Tacrolimus, Prednisone, and KZR-616 are established interventions for polymyositis based on available trial data [1, 3, 4, 5].
  • Abatacept showed a trend toward improvement in IMACS DOI at week 24, but the result did not reach statistical significance (p=0.083) 2.

AI synthesis of 8 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Brepocitinib 30 mg improved Total Improvement Score versus placebo in dermatomyositis patients over 52 weeks
Drug Pipeline RCT
Brepocitinib 30 mg improved Total Improvement Score versus placebo in dermatomyositis patients over 52 weeks New Pill Eases Stubborn Muscle and Skin Disease Symptoms
This Phase 3, double-blind, randomized, placebo-controlled trial enrolled 241 adults with dermatomyositis. The once-daily oral brepocitinib …
• Brepocitinib 30 mg significantly improves muscle strength and skin rashes • Helps adults with treatment-resistant dermatomyositis regain d…
May 14, 2026
Male sex and advanced age associated with higher risk of RP-ILD in anti-MDA5 dermatomyositis patients
Allergy & Immunology Meta-analysis
Male sex and advanced age associated with higher risk of RP-ILD in anti-MDA5 dermatomyositis patients Some Patients With This Rare Lung-Muscle Disease Face Faster Decline
This systematic review and meta-analysis of 15 studies evaluated factors associated with rapidly progressive interstitial lung disease (RP-I…
Men and older adults with a rare autoimmune lung disease are at higher risk of rapid, life-threatening lung damage, a new review finds.
Frontiers Apr 16, 2026
Mendelian randomization suggests potential causal link between severe COVID-19 and polymyositis risk
Rheumatology Cohort
Mendelian randomization suggests potential causal link between severe COVID-19 and polymyositis risk Severe COVID-19 May Set Off a Rare Muscle Disease, Genetic Study Hints
A single-center cohort study of 108 hospitalized COVID-19 patients used Mendelian randomization to explore associations with polymyositis.
A new genetic analysis adds to growing concern that severe COVID-19 can quietly trigger immune attacks on healthy muscle months later.
Frontiers Apr 13, 2026
JSLE linked to higher CVD risk factors than JDM in adults with childhood-onset autoimmune diseases
Rheumatology Cohort
JSLE linked to higher CVD risk factors than JDM in adults with childhood-onset autoimmune diseases Study compares heart health risks in adults with childhood-onset lupus or dermatomyositis
A single-centre longitudinal cohort study of 76 JSLE and 79 JDM adults found JSLE had higher hypertension, dyslipidaemia, and cholesterol le…
Adults with childhood lupus face higher heart risks like high blood pressure and cholesterol compared to those with juvenile dermatomyositis…
medRxiv Apr 13, 2026