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)

Phase 3RecruitingNCT06455449

AstraZeneca240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

240

Conditions

Polymyositis, Dermatomyositis

Interventions

Anifrolumab (blinded)COMBINATION_PRODUCT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Capable of giving informed consent. Inclusion Criteria: 1. 18 - 75 years old 2. Body weight 40 kg - ≤ 100 kg 3. Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis. 4. Moderate or severe disease activity per core set measurements. 5. Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose. 6. No history of active tuberculosis or severe COVID-19. 7. Male and female participants must follow contraception guidelines. Exclusion Criteria: 1. 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). 2. PM and DM patients at a high risk of malignancy. 3. Participants with rapidly progressive interstitial lung disease. 4. 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. 5. Any history of severe case of herpes zoster infection 6. History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV . 7. Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF. 8. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization. 9. Recent non-opportunistic infection requiring hospitalization or anti-infective treatment. 10. Recent or concurrent enrollment in another clinical study with an investigational product. 11. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding

Locations (220)

Research Site

Irvine, California, United States

RECRUITING

Research Site

Aurora, Colorado, United States

RECRUITING

Research Site

Denver, Colorado, United States

NOT_YET_RECRUITING

Research Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Total Improvement Score (TIS) ≥ 40 response

Participants who have at least moderate improvement in disease activity TIS ≥ 40 and has not met "confirmed deterioration" criteria at 2 consecutive visits

Time frame: 52 week

Secondary Outcomes

Manual Muscle Testing 8 (MMT-8) (CSM)

MMT-8 (CSM) change from baseline at Week 52.

Time frame: 52 week

Oral corticosteroid dose ≤ 7.5 mg/day

Participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52.

Time frame: 52 week

Moderate improvement in disease activity in participants with polymyositis (PM)

Participants with PM who have at least moderate improvement in disease activity (TIS ≥ 40) at Week 52.

Time frame: 52 week

Moderate improvement in disease activity in dermatomyositis (DM) participants.

Participants with DM who have at least moderate improvement in disease activity (TIS ≥ 40).

Time frame: 52 week

Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)

CDASI activity change from baseline at Week 8 in DM participants only.

Time frame: 8 week

Manual Muscle Testing 8 (MMT-8) in PM participants

MMT-8 change from baseline at Week 52 in PM participants only.

Time frame: 52 Week

Manual Muscle Testing 8 (MMT-8) in DM participants

MMT-8 change from baseline at Week 52 in DM participants only.

Time frame: 52 Week

Core Set Measures (CSMs)

Change from baseline at Week 52 in CSMs: * PGA * PtGA * Muscle enzymes * MDAAT extra-muscular disease activity * HAQ-DI

Time frame: 52 week

Oral corticosteroid dose ≤ 7.5 mg/day in PM participants

PM participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52

Time frame: 52 week

Oral corticosteroid dose ≤ 7.5 mg/day in DM participants

DM participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52.

Time frame: 52 week

Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA)

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)

Time frame: 8, 24, & 52 week

5-D itch

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 52

Time frame: 8, 24, & 52 week

Total Improvement Score (TIS) ≥ 20 Response

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

Time frame: 8 week

Total Improvement Score ≥ 60 Response

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

Time frame: 52 week

Cumulative Corticosteroid Use

* 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

Time frame: 24, 52 week

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)

Overview

Conditions

Interventions

Eligibility

Locations (220)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts