A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
- Conditions
- Polymyositis, Dermatomyositis
- Interventions
- Combination Product: Anifrolumab (blinded)Other: PlaceboCombination Product: Anifrolumab (unblinded, open label)
- Registration Number
- NCT06455449
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 18 - 75 years old
- Body weight 40 kg - ≤ 100 kg
- Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.
- Moderate or severe disease activity per core set measurements.
- Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.
- No history of active tuberculosis or severe COVID-19.
- Male and female participants must follow contraception guidelines.
- Participants with documented inclusion body myositis (IBM), immune mediation necrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years prior to signing the ICF), drug-induced myositis, cancer associated myositis, amyopathic DM, and non inflammatory myopathies (eg, muscular dystrophies).
- PM and DM patients at a high risk of malignancy.
- Participants with rapidly progressive interstitial lung disease.
- Participants with severe muscle damage or permanent weakness due to non-PM or non-DM conditions (i.e. stroke) as per the investigator's opinion.
- Any history of severe case of herpes zoster infection
- History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV .
- Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
- Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization.
- Recent non-opportunistic infection requiring hospitalization or anti-infective treatment.
- Recent or concurrent enrollment in another clinical study with an investigational product.
- Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anifrolumab (subcutaneous weekly injection) Anifrolumab (blinded) Anifrolumab subcutaneous injection once weekly Anifrolumab (subcutaneous weekly injection) Anifrolumab (unblinded, open label) Anifrolumab subcutaneous injection once weekly Placebo (subcutaneous weekly injection) Placebo Matched placebo control subcutaneous injection once weekly
- Primary Outcome Measures
Name Time Method Total Improvement Score (TIS) ≥ 40 response 52 week Participants who have at least moderate improvement in disease activity TIS ≥ 40 and has not met "confirmed deterioration" criteria at 2 consecutive visits
- Secondary Outcome Measures
Name Time Method Manual Muscle Testing 8 (MMT-8) (CSM) 52 week MMT-8 (CSM) change from baseline at Week 52.
Oral corticosteroid dose ≤ 7.5 mg/day 52 week Participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52.
Moderate improvement in disease activity in participants with polymyositis (PM) 52 week Participants with PM who have at least moderate improvement in disease activity (TIS ≥ 40) at Week 52.
Moderate improvement in disease activity in dermatomyositis (DM) participants. 52 week Participants with DM who have at least moderate improvement in disease activity (TIS ≥ 40).
Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) 8 week CDASI activity change from baseline at Week 8 in DM participants only.
Manual Muscle Testing 8 (MMT-8) in PM participants 52 Week MMT-8 change from baseline at Week 52 in PM participants only.
Manual Muscle Testing 8 (MMT-8) in DM participants 52 Week MMT-8 change from baseline at Week 52 in DM participants only.
Core Set Measures (CSMs) 52 week Change from baseline at Week 52 in CSMs:
* PGA
* PtGA
* Muscle enzymes
* MDAAT extra-muscular disease activity
* HAQ-DIOral corticosteroid dose ≤ 7.5 mg/day in PM participants 52 week PM participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52
Oral corticosteroid dose ≤ 7.5 mg/day in DM participants 52 week DM participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52.
Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA) 8, 24, & 52 week DM Participants with CDA-IGA ≥ 2 at baseline who achieve:
* CDA-IGA score ≤ 1 at Week 8 (yes/no)
* CDA-IGA score ≤ 1 at Week 24 (yes/no)
* CDA-IGA score ≤ 1 at Week 52 (yes/no)5-D itch 8, 24, & 52 week DM participants with CDASI activity \> 14 at baseline only:
* 5-D itch change from baseline at Week 8
* 5-D itch change from baseline at Week 24
* 5-D itch change from baseline at Week 52Total Improvement Score (TIS) ≥ 20 Response 8 week Participants who have at least minimal improvement in disease activity TIS ≥ 20 at Week 8 and has not met "confirmed deterioration" criteria at 2 consecutive visits up and including Week 8
Total Improvement Score ≥ 60 Response 52 week Participants who have major improvement in disease activity TIS ≥ 60 at week 52 and has not met "confirmed deterioration" criteria at 2 consecutive visits up to and including Week 52
Cumulative Corticosteroid Use 24, 52 week * Cumulative corticosteroids use as determined by the normalized standardized AUC from baseline up to and including Week 24
* Cumulative corticosteroids use as determined by the normalized standardized AUC from baseline up to and including Week 52
Trial Locations
- Locations (1)
Research Site
🇻🇳Hue, Vietnam