CAPTIVATE Trial Design: A Pivotal Phase 3 Study of Claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy
Jeffrey Allen1, Luis Querol2, Filip Eftimov3, Stojan Peric4, Tina Dysgaard5, Yusuf Rajabally6, Thomas Harbo7, Eduardo Nobile-Orazio8, Hans Katzberg9, Jon Katz10, James Sheffield11, Luke Hickey11, Nuria Carrillo11, Richard Lewis12
1University of Minnesota, 2Hospital de la Santa Creu i Sant Pau, 3Amsterdam UMC, 4University of Belgrade, 5University of Copenhagen, 6University of Aston, 7Aarhus University Hospital, 8Milan University, IRCCS Humanitas Clinical Institute, 9Institute of Medical Science, 10California Pacific Medical Center, 11Dianthus Therapeutics, 12Cedars-Sinai Medical Center
Objective:
CAPTIVATE Phase 3 study (NCT06858579) evaluates claseprubart in a broad population of adults aged 18–75 with a diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP).
Background:
Claseprubart (DNTH103) is a potent monoclonal antibody that selectively binds to active C1s, inhibiting the classical complement pathway.
Design/Methods:
CAPTIVATE is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study assessing the efficacy and safety of claseprubart in adults with a diagnosis of CIDP per 2021 EAN/PNS guidelines confirmed by an independent adjudication panel. Eligible participants are responders to standard-of-care (SOC) therapy (immunoglobulins [Ig] or oral corticosteroids [OCS]), refractory to SOC, or treatment-naïve. In SOC responders, Ig will be discontinued 1 week before dosing and OCS tapered and continued. Part A is open-label with an initial IV loading dose followed by biweekly subcutaneous claseprubart up to 13 weeks. Responders (≥1-point improvement in adjusted INCAT) are randomized (N=64/arm) into a placebo-controlled, double-blind period for 52 weeks (Part B).
Results:
The primary endpoint is time to relapse in Part B with key secondary endpoints evaluating I-RODS and grip strength changes. Those who complete or relapse (≥1-point worsening in adjusted INCAT) in Part B may enter an optional open-label extension (up to 104 weeks). Upon discontinuation, participants enter a 40-week safety follow-up.
Conclusions:
CAPTIVATE is an innovative, rigorous Phase 3 study evaluating claseprubart, an active C1s inhibitor administered as a convenient biweekly injection, in CIDP. CAPTIVATE was launched in 2025 and is actively enrolling participants in North and South America, Europe, and Asia.
Generative AI Usage
No, did not use generative AI in the drafting or editing in this abstract.
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