Daxdilimab for Inflammatory Myositis

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Amgen

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing daxdilimab, a new medicine, to see if it can help patients with specific muscle and skin diseases by reducing inflammation and symptoms. The study focuses on patients with dermatomyositis or anti-synthetase inflammatory myositis.

Research Team

Principal Investigator

Amgen

Eligibility Criteria

This trial is for adults aged 18-75 with a diagnosis of dermatomyositis (DM) or anti-synthetase inflammatory myositis (ASIM), meeting specific criteria like muscle weakness and elevated muscle enzymes. Participants must not have severe infections, other connective tissue diseases that affect assessment, significant organ damage, or be pregnant. They should agree to potentially taper off corticosteroids.

Inclusion Criteria

Diagnosis of definite or probable myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria

I am currently experiencing active muscle inflammation.

I am between 18 and 75 years old.

See 2 more

Exclusion Criteria

I have myositis with another connective tissue disease, making treatment response hard to assess.

I have had significant heart problems in the last 6 months.

Severe herpes virus family infection at any time prior to randomization

See 14 more

Treatment Details

Interventions

Daxdilimab (Monoclonal Antibodies)
Placebo (Other)

Trial OverviewThe study tests Daxdilimab's effectiveness compared to a placebo in reducing disease activity by week 24. It also looks at its impact on skin symptoms and the possibility of lowering corticosteroid use. Additionally, it will assess how the body processes the drug and any potential immune response to it.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DaxdilimabExperimental Treatment1 Intervention

Daxdilimab will be administered by subcutaneous (SC) injection during the 24-week treatment period followed by an 8-week safety follow up. Prior to amendment 2 participants could enter an open-label extension period from weeks 24-48. For those participants already in the open-label extension, they will stop dosing and enter the safety follow up.

Group II: PlaceboPlacebo Group2 Interventions

Matching placebo will be administered by SC injection during the 24-week treatment period followed by an 8-week safety follow up. Prior to amendment 2 participants could enter an open-label extension period from weeks 24-48 and receive daxdilimab. For those participants already in the open-label extension, they will stop dosing and enter the safety follow up.