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NCT05581199 · ClinicalTrials.gov registry record · Phase 2
To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP
A Phase 2 study of Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by Immunovant Sciences.
- Active
- Registry status
- Phase 2
- Development phase
- 277
- Enrollment target
- 20
- Study locations
NCT05581199: Active Phase 2 study of Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by Immunovant Sciences.
NCT05581199 is a Phase 2 study of Chronic Inflammatory Demyelinating Polyneuropathy that is active but no longer recruiting, run by Immunovant Sciences. The registered enrollment target is 277 participants, above the 135-participant average among 11 other Chronic Inflammatory Demyelinating Polyneuropathy trials with a reported enrollment target (105% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05581199, a Phase 2 study of Chronic Inflammatory Demyelinating Polyneuropathy, is active but no longer recruiting, sponsored by Immunovant Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 277 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multi-center, randomized, quadruple-blind, placebo-controlled study to evaluate the efficacy and safety of batoclimab in adult participants with active CIDP. The study includes an up to 4-week Screening Period, an up to 12-week Washout Period, a 12-week Randomized Treatment Period (Period 1), an up to 24-week Randomized Withdrawal Period (Period 2), an up to 52-week Long-term Extension (LTE) Period (optional), and Safety Follow-up 4 weeks after the last dose of study treatment. The total study duration will be up to approximately 109 weeks. Eligible participants will be assigned to one of four cohorts based upon their baseline CIDP treatment (Cohorts A and D - immunoglobulin \[Ig\] or plasma exchange \[PLEX\]; Cohort B - corticosteroids; Cohort C - naive or untreated in previous 3-24 months) and whether they meet diagnosis according to the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria (Cohorts A, B, and C) or clinical criteria only (Cohort D) at the time of screening.
Primary Outcome
Relapse is defined as a worsening (increase) of \>=1 point on adjusted inflammatory neuropathy cause and treatment (AdjINCAT) score at any time point during Period 2 relative to Period 2 Baseline which is sustained at a Follow-Up visit 1 week later. The INCAT disability scale is a widely used and validated efficacy assessment of neurologic dysfunction in CIDP. Upper and lower limb dysfunction are each separately assessed on a scale of 0-5 and results are summed together for a total composite sco
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
- DRUG Batoclimab 340 mg SC weekly
Study Locations (20)
Florida
- Site Number - 1600 - Boca Raton
- Site Number - 1609 - Jacksonville
- Site Number - 1631 - Orlando
- Site Number - 1629 - Orlando
- Site Number - 1617 - Ormond Beach
- Site Number - 1620 - Port Charlotte
- Site Number - 1633 - Rockledge
- Site Number - 1604 - St. Petersburg
California
- Site Number - 1618 - Carlsbad
- Site Number - 1634 - Los Angeles
- Site Number - 1619 - Orange
- Site Number - 1608 - San Francisco
Colorado
- Site Number - 1625 - Aurora
- Site Number - 1636 - Fort Collins
Arizona
- Site Number - 1603 - Scottsdale
Connecticut
- Site Number - 1621 - New Haven
District of Columbia
- Site Number - 1630 - Washington D.C.
Illinois
- Site Number - 1607 - O'Fallon
Kansas
- Site Number - 1602 - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What the registry record for NCT05581199 still lists
NCT05581199 is an interventional study that assigns participants to a tested intervention. The registered 277 participants enrollment target is mid-sized for trials with a published cap, above the 135-participant average among 11 other Chronic Inflammatory Demyelinating Polyneuropathy trials with a reported enrollment target (105% higher).
The record links to 1 condition, with Chronic Inflammatory Demyelinating Polyneuropathy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05581199 names 20 study sites across 9 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05581199 about?
NCT05581199 is a clinical study titled "To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP". This is a multi-center, randomized, quadruple-blind, placebo-controlled study to evaluate the efficacy and safety of batoclimab in adult participants with active CIDP. The study includes an up to 4-week Screening Period, an up to 12-week Washout Period, a 12-week Randomized Treatment Period (Period ...
What is the current status of trial NCT05581199?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 277 participants. The study started on 2022-12-15. Estimated completion is 2027-01.
What conditions does trial NCT05581199 study?
This clinical trial studies the following conditions: Chronic Inflammatory Demyelinating Polyneuropathy.
What interventions are being tested in trial NCT05581199?
The interventions under investigation include: Placebo (DRUG), Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly (DRUG), Batoclimab 340 mg SC weekly (DRUG).
Who is sponsoring clinical trial NCT05581199?
This trial is sponsored by Immunovant Sciences, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05581199 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05581199's enrollment target sits among peer trials
277 2nd of 11 the highest of 11 other Chronic Inflammatory Demyelinating Polyneuropathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Inflammatory Demyelinating Polyneuropathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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