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Immunoglobulin

Human Immunoglobulin G for Dermatomyositis (RECLAIIM Trial)

Phase 3
Waitlist Available
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Corticosteroid daily dose less than that or equal to 20 mg prednisolone equivalent
Disease severity defined by Physician global activity visual analog scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 ≤ 142 or CDASI total activity score ≥ 14.
Must not have
Evidence of active malignant disease or malignancies diagnosed within the previous 5 years
Cancer-associated myositis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 17, 21, and 25
Awards & highlights
Pivotal Trial

Summary

This trial tests if injecting immunoglobulin proteins under the skin can help adults with dermatomyositis, a muscle disease, by boosting their immune system and reducing inflammation. Immunoglobulin has been used in dermatomyositis, showing improvements in muscle strength and skin rashes.

Who is the study for?
Adults over 18 with dermatomyositis can join this trial. They should be on a low dose of steroids and have moderate disease severity, confirmed by specific scales and muscle tests. People with recent cancer, significant past damage from the disease, or improvement before starting the study cannot participate.
What is being tested?
The trial is testing IgPro20, a human immunoglobulin G given under the skin against a placebo to see if it helps improve symptoms in adults with dermatomyositis. It's randomized and double-blind so neither doctors nor patients know who gets real treatment or placebo.
What are the potential side effects?
Possible side effects include reactions at the injection site like redness or pain, headaches, nausea, fatigue, fever, chills and potential increased risk of infections due to immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I take 20 mg or less of prednisolone or its equivalent daily.
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My doctor rates my disease as moderately severe or worse.
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I have been diagnosed with a type of muscle inflammation disease according to EULAR/ACR criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with cancer or had active cancer in the last 5 years.
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I have muscle inflammation related to my cancer.
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My doctor rates my condition as significantly damaged or improved recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 17, 21, and 25
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 17, 21, and 25 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Responder Rate
Secondary study objectives
Mean TIS
Mean Total Improvement Score (TIS)
Mean change difference (IgPro20 minus placebo) in CDASI
+6 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IgPro20Experimental Treatment1 Intervention
human immunoglobulin G administered subcutaneously
Group II: PlaceboPlacebo Group1 Intervention
human albumin solution administered subcutaneously

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Dermatomyositis (DM) include immunosuppressive agents like glucocorticoids, methotrexate, and mycophenolate mofetil, as well as immunomodulatory therapies such as intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG) like IgPro20. These treatments primarily work by modulating the immune response to reduce inflammation and muscle damage. For instance, SCIG provides a steady supply of immunoglobulins that can neutralize autoantibodies and modulate immune cell activity, thereby decreasing the autoimmune attack on muscle tissues. This is crucial for DM patients as it helps in managing symptoms, improving muscle strength, and preventing disease progression.
Inflammatory myopathies: clinical, diagnostic and therapeutic aspects.

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor
198 Previous Clinical Trials
1,211,325 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,268 Previous Clinical Trials
503,720 Total Patients Enrolled

Media Library

IgPro20 (Immunoglobulin) Clinical Trial Eligibility Overview. Trial Name: NCT04044690 — Phase 3
Dermatomyositis Research Study Groups: IgPro20, Placebo
Dermatomyositis Clinical Trial 2023: IgPro20 Highlights & Side Effects. Trial Name: NCT04044690 — Phase 3
IgPro20 (Immunoglobulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04044690 — Phase 3
~51 spots leftby May 2028