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 Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)
The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).
The study includes the following periods:
Inclusion Criteria:
Must have given written informed consent before any study-related activities are carried out.
Weight range between 40 kilograms (kg) and 120 kg.
Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.
CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.
Must be neurologically stable.
Must have an INCAT score between 2 and 9 inclusive.
Must fulfill one of the following treatment conditions for CIDP:
Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.
Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.
Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.
Exclusion Criteria:
clinicaltrials@dianthustx.com929-999-4055
Buenos Aires, Buenos Aires, Argentina
Saint Leonards, New South Wales 2065, Australia