Human Immunoglobulin G for Dermatomyositis

(RECLAIIM Trial)

No longer recruiting at 202 trial locations

Overseen By Trial Registration Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: CSL Behring

Disqualifiers: Cancer, Active malignancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 70

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IgPro20, a subcutaneous immunoglobulin, to determine its effectiveness for dermatomyositis, a condition causing muscle weakness and skin rashes. Participants will receive either IgPro20 or a placebo, a harmless substance resembling the drug but without effect, to compare treatment effectiveness. The goal is to see if IgPro20 improves symptoms more effectively than the placebo. The trial seeks adults diagnosed with dermatomyositis who have noticeable skin symptoms or muscle weakness and are on a stable, low dose of corticosteroids, a medication that reduces inflammation. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants must have a corticosteroid daily dose of 20 mg or less, which might imply some restrictions on steroid use.

Is there any evidence suggesting that IgPro20 is likely to be safe for humans?

Research has shown that IgPro20, a treatment for dermatomyositis (DM), is generally well-tolerated. Previous patients demonstrated that IgPro20, administered as an injection under the skin, is a safe and effective option for treating conditions similar to DM. One study found it to be a safe alternative to intravenous immunoglobulin (IVIg), another type of immune therapy.

Few reports of serious side effects suggest that most people handle the treatment well. However, like any medical treatment, mild side effects, such as redness or swelling at the injection site, may occur. Discussing potential risks and benefits with healthcare providers before joining a clinical trial is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dermatomyositis?

Researchers are excited about IgPro20 for dermatomyositis because it introduces a new approach with human immunoglobulin G, administered subcutaneously. Unlike traditional treatments that often focus on immunosuppressive drugs like corticosteroids or methotrexate, IgPro20 offers a different mechanism by delivering antibodies directly, potentially reducing inflammation more effectively. This method of subcutaneous delivery can also make it easier for patients to receive treatment regularly, potentially improving adherence and outcomes. Overall, IgPro20 could offer a promising alternative by directly targeting the immune components involved in dermatomyositis, potentially with fewer side effects.

What evidence suggests that IgPro20 might be an effective treatment for dermatomyositis?

Research shows that IgPro20, a type of human antibody administered under the skin, may help treat dermatomyositis (DM). In this trial, participants will receive either IgPro20 or a placebo. Studies have found that antibody treatments can effectively reduce symptoms like muscle weakness and skin rashes in DM. One study found that patients receiving similar antibody treatments had stronger muscles and fewer flare-ups of the disease. Additionally, these patients maintained stable levels of creatine kinase, an enzyme related to muscle damage, which suggested less muscle inflammation. Overall, these findings suggest that IgPro20 could be a helpful treatment for people with DM. ^{2 6 7 8 9}

Who Is on the Research Team?

Study Director

Principal Investigator

CSL Behring

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I take 20 mg or less of prednisolone or its equivalent daily.

My doctor rates my disease as moderately severe or worse.

I have been diagnosed with a type of muscle inflammation disease according to EULAR/ACR criteria.

Exclusion Criteria

I have been diagnosed with cancer or had active cancer in the last 5 years.

I have muscle inflammation related to my cancer.

My doctor rates my condition as significantly damaged or improved recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IgPro20 or placebo subcutaneously for 24 weeks

24 weeks

Regular visits for assessments at Weeks 17, 21, and 25

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

Visits up to Week 53

What Are the Treatments Tested in This Trial?

Interventions

• IgPro20

Trial Overview 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.

How Is the Trial Designed?

Group I: IgPro20 Experimental Treatment 1 Intervention

human immunoglobulin G administered subcutaneously

Group II: Placebo Placebo Group 1 Intervention

human albumin solution administered subcutaneously

IgPro20 is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Hizentra for:

• Chronic inflammatory demyelinating polyneuropathy
• Primary immunodeficiency

Approved in United States as Hizentra for:

• Chronic inflammatory demyelinating polyneuropathy
• Primary immunodeficiency

Approved in Canada as Hizentra for:

• Chronic inflammatory demyelinating polyneuropathy
• Primary immunodeficiency

Approved in Japan as Hizentra for:

• Chronic inflammatory demyelinating polyneuropathy
• Primary immunodeficiency

Approved in Switzerland as Hizentra for:

• Chronic inflammatory demyelinating polyneuropathy
• Primary immunodeficiency

Who Is Running the Clinical Trial?

CSL Behring

Lead Sponsor

Trials

204

Recruited

1,207,000+

Dr. Paul McKenzie

CSL Behring

Chief Executive Officer since 2023

PhD in Chemical Engineering from Carnegie Mellon University, B.S. in Chemical Engineering from the University of Pennsylvania

Dr. Bill Mezzanotte

CSL Behring

Chief Medical Officer since 2021

MD from Duke University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04044690

NCT04044690 | A Study to Evaluate the Efficacy, Safety, ... The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40616720/

Sub-analysis of the ProDERM Study Conclusion: IVIg was effective in treating pulmonary, skeletal, constitutional, and gastrointestinal manifestations of dermatomyositis. We ...

3. io.nihr.ac.uk io.nihr.ac.uk/wp-content/uploads/2024/03/28231-IgPro20-for-Dermatomyositis-V1.0-MAR2024-NON-CONF.pdf

IgPro20 for treating dermatomyositis This briefing reflects the evidence available at the time of writing and a limited literature search. It is not intended to be a definitive.

4. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2021.805705/full

Replacement and Immunomodulatory Activities of 20% ... Conclusions: This study suggests that 20% SCIg treatment represents a viable and safe treatment for PM/DM patients and a valid therapeutic ...

5. ard.eular.org ard.eular.org/article/S0003-4967(24)37476-X/fulltext

AB0834 Efficacy and safety of hizentra(®) in patients with ... All patients showed a favourable clinical response with normal CK serum levels and improvement in MRC and Rankin modified scores. No relapse of the disease ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04044690

NCT04044690 | A Study to Evaluate the Efficacy, Safety, ... The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured ...

7. humanforschung-schweiz.ch humanforschung-schweiz.ch/en/trial-search/study-detail/48565/translate/en/?cHash=66630a6d1476ff25df72bee49ff14eb8

A study to assess the efficacy, safety, and ... This is a 56-week study with the investigational drug IgPro20 (subcutaneous infusion/injection) for the treatment of adult patients with dermatomyositis (DM).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8801806/

A Single-Center Retrospective Study in Autoimmune Myositis ... This study suggests that 20% SCIg treatment represents a viable and safe treatment for PM/DM patients and a valid therapeutic alternative to IVIg.

9. academic.oup.com academic.oup.com/rheumatology/article/64/6/3657/8002919

A phase 2 randomized trial of safety and pharmacokinetics of ... The primary objective was the safety of sc immunoglobulin, IgPro20 (Hizentra, CSL Behring) in adults with dcSSc. Secondary objectives included pharmacokinetics ...