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Not Yet RecruitingNCT06858722

Ripertamab for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy

Safety and Efficacy of Ripertamab in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (RIPERT-CIDP): a Randomised, Double-blind, Multicentre, Placebo-controlled Phase 3 Trial

Status
Not Yet Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
175 (estimated)
Sponsor
Zhongming Qiu · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The goal of this clinical trial is to learn if ripertamab works to treat chronic inflammatory demyelinating polyneuropathy. It will also learn about the safety of ripertamab. The main questions it aims to answer are: Does ripertamab reduce the risk of recurrence in patients? What medical problems do participants have when taking ripertamab? Researchers will compare ripertamab to a placebo (a look-alike substance that contains no drug) to see if ripertamab works to treat chronic inflammatory demyelinating polyneuropathy. Participants will: A single intravenous infusion of drug ABC or placebo. Visit the clinic for checkups and tests during W1, W2, W4, W8, W12 Keep a diary of their symptoms and the number of times they undergo rescue therapy

Conditions

Interventions

TypeNameDescription
DRUGripertamabOn Day 1 of the treatment period, an intravenous infusion of Ripertamab at a dose of 375 mg/m² body surface area will be administered.
DRUGPlaceboOn Day 1 of the treatment period, an intravenous infusion of Placebo at a dose of 375 mg/m² body surface area will be administered.

Timeline

Start date
2025-03-15
Primary completion
2027-06-30
Completion
2027-12-31
First posted
2025-03-05
Last updated
2025-03-05

Source: ClinicalTrials.gov record NCT06858722. Inclusion in this directory is not an endorsement.