A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of DNTH103 in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)
A Research Study to Learn Whether DNTH103 Is Safe and Effective for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Sponsor: Dianthus Therapeutics, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAV5604
U.S. Govt. ID: NCT06858579
Contact: Jorge Cabrera, CRC: 212-305-7462 / jec2273@cumc.columbia.edu
Additional Study Information: This is a global, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of DNTH103 in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The study is comprised of a Part A and a Part B and an Optional open label extension. Treatment duration will be 65 weeks with an Optional open label extension (OLE): up to 104 weeks for participants who complete the 52-week treatment period or who relapse in Part B. Participant must be 18-75 years of age (inclusive) at Screening.
Investigator
Thomas Brannagan, MD
Do You Qualify?
Are you 18 years old or older? Yes No
Do you have CIDP? Yes No
Is your current weight between 40 kg and 120 kg? Yes No
Do you have prior history (at any time) of N. meningitidis infection or active tuberculosis (TB)? Yes No
Do you have history of active malignancy other than basal cell carcinoma of the skin within the last 5 years? Yes No
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For more information, please contact:
Jorge Cabrera, CRC
jec2273@cumc.columbia.edu
212-305-7462