Human Immunoglobulin G for Dermatomyositis

(RECLAIIM Trial)

Recruiting at 185 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

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 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