To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly — DRUG
  Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
• Batoclimab 340 mg SC weekly — DRUG
  Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
• Placebo — DRUG
  Matching placebo SC

Study Details

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.

Key Dates

Start date

Dec 15, 2022

Status verified

Nov 2024

Primary completion

Jan 31, 2026

Completion

Jan 31, 2027

Study Design

Enrollment

277 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Period 1: Cohort A, Dose 1
• Experimental: Treatment Period 1: Cohort A, Dose 2
• Experimental: Treatment Period 1: Cohort B, Dose 1
• Experimental: Treatment Period 1: Cohort B, Dose 2
• Experimental: Treatment Period 1: Cohort C, Dose 1
• Experimental: Treatment Period 1: Cohort C, Dose 2
• Experimental: Treatment Period 1: Cohort D, Dose 1
• Experimental: Treatment Period 1: Cohort D, Dose 2
• Experimental: Withdrawal Period 2: Cohort A, Dose 2
• Experimental: Withdrawal Period 2: Cohort A, Placebo
• Experimental: Withdrawal Period 2: Cohort B, Dose 2
• Experimental: Withdrawal Period 2: Cohort B, Placebo
• Experimental: Withdrawal Period 2: Cohort C, Dose 2
• Experimental: Withdrawal Period 2: Cohort C, Placebo
• Experimental: Withdrawal Period 2: Cohort D, Dose 2
• Experimental: Withdrawal Period 2: Cohort D, Placebo
• Experimental: LTE Period: With Relapse in Period 2: Dose 1 and Dose 2
  Participants will receive Dose 1 for the initial 4 weeks only and Dose 2 for the remaining 48 weeks.
• Experimental: LTE Period: Without Relapse in Period 2: Dose 2
  Participants will receive Dose 2 for all 52 weeks.

Primary Outcome Measure

Period 2, Cohort A: Proportion of participants who remain relapse-free at Week 36 [ Time Frame: Week 36 ]

Locations (33)

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