A Phase 2 interventional study of Batoclimab in Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by Immunovant Sciences GmbH. Terminated at 30 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Immunovant Sciences GmbH · Phase 2, Interventional, and Treatment
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.
129 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 49 are open to participants now.
This study's enrollment of 26 is below the median of 40 across 82 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →Immunovant Sciences GmbH is the lead sponsor of 19 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Note: Other protocol specified criteria may apply.
Drug: Batoclimab
Batoclimab 340 mg SC QW
Also known as: IMVT-1401
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
Change from Baseline in Adjusted inflammatory Neuropathy Cause and Treatment (aINCAT)
The INCAT disability scale is a widely used and validated efficacy assessment of neurologic dysfunction in CIDP and will be used for measurement of clinical response.
Time frame: Up to 52 weeks
Change from Baseline in Mean Grip Strength
Mean Grip strength provides an objective, quantitative and immediate assessment of strength impairment.
Time frame: Up to 52 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating→
Immunovant Sciences GmbH