An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Batoclimab.
- Who it may be relevant to
- Registry conditions: Chronic Inflammatory Demyelinating Polyneuropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Belgium, Brazil, Germany +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label Extension Study to Assess Long-term Safety and Tolerability of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Overview
This is an open-label extension (OLE) study designed to evaluate the long-term safety and tolerability of batoclimab in participants with CIDP who have completed Study IMVT-1401-2401 (NCT05581199). In this study, participants will receive 340 mg of batoclimab subcutaneously (SC) once weekly (QW) for up to 52 weeks. Upon completion of the Week 52 or early termination (ET) Visit, participants will transition into the 4-week Follow-up Period, which concludes with a Follow-up Visit approximately 28 (± 7) days after the Week 52 or ET Visit.
Interventions
- Drug Batoclimab
Batoclimab 340 mg SC QW
Primary outcome measures
- Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation [Time frame: Up to 52 weeks]
Secondary outcome measures (2)
- Change from Baseline in Adjusted inflammatory Neuropathy Cause and Treatment (aINCAT) [Time frame: Up to 52 weeks]
- Change from Baseline in Mean Grip Strength [Time frame: Up to 52 weeks]
Eligibility criteria
Inclusion criteria
- Any participant who has completed Study IMVT-1401-2401
- Female participants of childbearing potential must agree to use a highly effective method of birth control
- Female participants must agree not to donate eggs throughout the study and for 90 days after the final study treatment administration
- Male participants must agree to use 1 highly effective contraception method with partners of childbearing potential throughout the study period and for 90 days after the final study treatment administration
- Male participants must agree not to donate sperm throughout the study period and for 90 days after the final study treatment administration
- Agree not to participate in another interventional study while on treatment
Exclusion criteria
- Participant has any medical condition (acute or chronic illness) or psychiatric condition, including autoimmune disease or neurologic disease other than CIDP, or known history of drug or alcohol abuse that, in the opinion of the Investigator, could jeopardize the participant's ability to participate in this study, compromise accurate assessment of CIDP symptoms or otherwise interfere with the course and conduct of the study.
- Participant intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of batoclimab
- Participant has an ongoing SAE or a medical condition in the IMVT-1401-2401 study that the Investigator considers putting the participant at a significantly increased risk of participating in Study IMVT-1401-2402
- Participant has received Standard of Care therapy for treatment of a relapse in Study IMVT-1401-2401
Note: Other protocol specified criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Poland · 6 centers
- Site Number - 3207 — Poznan
- Site Number - 3208 — Krakow
- Site Number - 3209 — Krakow
- Site Number - 3210 — Lublin
- Site Number - 3206 — Lublin
- Site Number - 3201 — Katowice
United States · 5 centers
- Site Number - 1621 — New Haven
- Site Number - 1617 — Ormond Beach
- Site Number - 1611 — Nicholasville
- Site Number - 1610 — Charlotte
- Site Number - 1601 — Austin
Argentina · 4 centers
- Site Number - 7753 — Rosario
- Site Number - 7751 — Rosario
- Site Number - 7750 — Buenos Aires
- Site Number - 7752 — San Miguel de Tucumán
Brazil · 3 centers
- Site Number - 9103 — Brasília
- Site Number - 9101 — Curitiba
- Site Number - 9100 — Ribeirão Preto
Greece · 3 centers
- Site Number - 6341 — Pátrai
- Site Number - 6344 — Athens
- Site Number - 6347 — Larissa
Italy · 3 centers
- Site Number - 6305 — Bologna
- Site Number - 6309 — Rome
- Site Number - 6307 — Milan
Romania · 2 centers
- Site Number - 8403 — Timișoara
- Site Number - 8400 — Constanța
Belgium · 1 center
- Site Number - 4680 — Leuven
Germany · 1 center
- Site Number - 6702 — Leipzig
Serbia · 1 center
- Site Number - 8501 — Belgrade
Slovakia · 1 center
- Site Number - 8603 — Prešov
Identifiers
NCT: NCT07188844 · IMVT-1401-2402