Efficacy and Safety Study of Nipocalimab for Adults with Active Inflammatory Myopathies
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants with Active Idiopathic Inflammatory Myopathies
IRAS ID
1005992
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-005202-98
ISRCTN Number
ISRCTN98762360
Clinicaltrials.gov Identifier
Research summary
Idiopathic Inflammatory Myopathies (IIM), group of rare diseases marked by long-standing inflammation and weakness of muscles used for movement. The primary symptoms of IIM are muscle weakness (develops over a period of time), joint pain, and general tiredness. Nipocalimab is an antibody (protein made in the body in response to foreign substance) that blocks a specific antibody immunoglobulin G (IgG) binding site on neonatal fragment crystallisable receptor* (FcRn). FcRn is responsible for controlling IgG levels in the body. Nipocalimab blocks FcRn, resulting in reduction of IgG which may reduce inflammation in muscles. *Protein that binds to specific molecule. This study is designed to see if nipocalimab is better than placebo. This will be assessed by measuring how many participants achieve improvement in symptoms of IIM.
Study will include male and female participants 18 years old or above
The study will be conducted as:
1. Screening (<=6 weeks)
2. Double-blind* period (52 weeks): Participants will receive 1 of 2 below treatments:
• Nipocalimab: Based on body weight, as an injection in vein at Week 0 up to Week 50.
• Placebo: Similar as nipocalimab arm.
*Neither the researcher nor participant knows which treatment is being given.
Participants will also receive their current IIM medications. The amount of these medications may be reduced if the participant’s IIM is not getting worse.
3. Long-term extension (LTE) (48 Weeks): Eligible participants will enter LTE and receive nipocalimab from Week 52 to Week 98, or until sponsor decision to stop treatment.
4. Safety follow-up (8 weeks after last dose of study treatment).
During the study, some tests such as blood tests, physical examinations, and vital signs will be performed. Side effects will be recorded until study ends (up to 112 weeks)REC name
North West - Haydock Research Ethics Committee
REC reference
22/NW/0324
Date of REC Opinion
29 Nov 2022
REC opinion
Further Information Favourable Opinion