To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP
Public ClinicalTrials.gov record NCT05581199. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants With Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05581199
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 94 participants
Conditions and interventions
Interventions
- Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly Drug
- Batoclimab 340 mg SC weekly Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 15, 2022 (Actual)
- Primary completion
- Jul 20, 2026 (Actual)
- Completion
- Jul 20, 2026 (Actual)
- Last update posted
- Aug 11, 2026
2022 – 2026
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site Number - 1603 | Scottsdale | Arizona | 85028 | — |
| Site Number - 1634 | Los Angeles | California | 90033-5330 | — |
| Site Number - 1625 | Aurora | Colorado | 80045 | — |
| Site Number - 1621 | New Haven | Connecticut | 06519 | — |
| Site Number - 1629 | Orlando | Florida | 32806-5411 | — |
| Site Number - 1617 | Ormond Beach | Florida | 32174 | — |
| Site Number - 1620 | Port Charlotte | Florida | 33952 | — |
| Site Number - 1633 | Rockledge | Florida | 32955 | — |
| Site Number - 1604 | St. Petersburg | Florida | 33713 | — |
| Site Number - 1602 | Kansas City | Kansas | 66160 | — |
| Site Number - 1611 | Nicholasville | Kentucky | 40356 | — |
| Site Number - 1605 | New York | New York | 10032 | — |
| Site Number - 1610 | Charlotte | North Carolina | 28207 | — |
| Site Number - 1614 | Portland | Oregon | 97239 | — |
| Site Number - 1623 | Philadelphia | Pennsylvania | 19104 | — |
| Site Number - 1624 | Philadelphia | Pennsylvania | 19104 | — |
| Site Number -1601 | Austin | Texas | 78759 | — |
| Site Number - 1606 | Houston | Texas | 77030 | — |
| Site Number - 1628 | San Antonio | Texas | 78229 | — |
| Site Number - 1632 | Seattle | Washington | 98195-0001 | — |
| Site Number - 1613 | Milwaukee | Wisconsin | 53226-3548 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 77 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05581199, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 11, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05581199 live on ClinicalTrials.gov.