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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 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.

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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.

Conditions Studied

Chronic Inflammatory Demyelinating Polyneuropathy

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

FieldValue
Enrollment Target 277 participants
Start Date 2022-12-15
Est. Completion 2027-01
Phase Phase 2

Sponsor

Immunovant Sciences

15 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05581199

The ClinicalTrials.gov registry entry for NCT05581199 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 277 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 135-participant average among 11 other Chronic Inflammatory Demyelinating Polyneuropathy trials with a reported enrollment target (105% higher). The listed sponsor is Immunovant Sciences, which has 15 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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