好色先生

好色先生

Explore the latest content from across our publications
Join The AAN

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

CAPTIVATE Trial Design: A Pivotal Phase 3 Study of Claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy
Autoimmune Neurology
P2 - Poster Session 02 (3:00 PM-4:00 PM)
1-004
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).

Claseprubart (DNTH103) is a potent monoclonal antibody that selectively binds to active C1s, inhibiting the classical complement pathway.

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).
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.

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.

Authors/Disclosures
Maria Ait Tihyaty (Johnson and Johnson Innovative Medicine)
PRESENTER 		Dr. Ait Tihyaty has received personal compensation for serving as an employee of Dianthus Therapeutics.
Jeffrey C. Allen, MD, FAAN (NYU Langone Medical Center) No disclosure on file
Luis Querol, MD, PhD (Hospital de la Santa Creu i Sant Pau) Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CSL Behring. The institution of Dr. Querol has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB. Dr. Querol has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for ArgenX. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dianthus. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alnylam. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Annexon. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avilar. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biocryst. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for KPL. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lycia. The institution of Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Querol has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Querol has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Querol has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. The institution of Dr. Querol has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ArgenX. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Grifols. The institution of Dr. Querol has received research support from GBS-CIDP Foundation International. The institution of Dr. Querol has received research support from Grifols. The institution of Dr. Querol has received research support from ISCIII. The institution of Dr. Querol has received research support from CIBERER. The institution of Dr. Querol has received research support from UCB. The institution of Dr. Querol has received research support from ArgenX.
Filip Eftimov, MD, PhD Dr. Eftimov has nothing to disclose.
Stojan Peric, MD, PhD Dr. Peric has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Argenx. Dr. Peric has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Dianthus. Dr. Peric has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for argenx. Dr. Peric has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Dianthus. Dr. Peric has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avidity. Dr. Peric has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for European Journal of Neurology.
Tina Dysgaard Tina Dysgaard has nothing to disclose.
Yusuf Rajabally, MD Prof. Rajabally has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Prof. Rajabally has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LFB. Prof. Rajabally has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CSL Behring. Prof. Rajabally has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Prof. Rajabally has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vitaccess. Prof. Rajabally has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Prof. Rajabally has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Grifols. The institution of Prof. Rajabally has received research support from CSL.
Thomas Harbo, MD, PhD (Aarhus Sygehus) Thomas Harbo, MD, PhD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Dianthus. Thomas Harbo, MD, PhD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Argenx. Thomas Harbo, MD, PhD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Thomas Harbo, MD, PhD has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Janssen.
Eduardo Nobile-Orazio, MD, PhD, FAAN (Milan University, IRCCS Humanitas Clinical Institute) Dr. Nobile-Orazio has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ArgenX, Belgium. Dr. Nobile-Orazio has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for LFB, France. Dr. Nobile-Orazio has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche, Switzerland. Dr. Nobile-Orazio has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CSL Behring. Dr. Nobile-Orazio has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen, USA. The institution of Dr. Nobile-Orazio has received research support from Takeda/Shire.
Hans D. Katzberg, MD, FAAN An immediate family member of Dr. Katzberg has received personal compensation for serving as an employee of Alexion. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Argenx. Dr. Katzberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dyne. Dr. Katzberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Katzberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for CSL Behring. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Johnson and Johnson. Dr. Katzberg has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Syneos Health. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ArgenX.
Jonathan S. Katz, MD (CPMC) Dr. Katz has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Griffols. Dr. Katz has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Katz has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Dianthus. Dr. Katz has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunovant. Dr. Katz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Kedrion. Dr. Katz has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Katz has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Griffols.
James K. Sheffield, MD (Dianthus Therapeutics) Dr. Sheffield has received personal compensation for serving as an employee of BMS.
Luke Hickey Mr. Hickey has received personal compensation for serving as an employee of Dianthus Therapeutics. Mr. Hickey has or had stock in Dianthus Therapeutics.
Nuria Carrillo, MD Dr. Carrillo has received personal compensation for serving as an employee of Dianthus Therapeutics. Dr. Carrillo has or had stock in Dianthus Therapeutics.Dr. Carrillo has or had stock in Moderna Therapeutics.
Richard A. Lewis, MD, FAAN (Cedars-Sinai Medical Center) Dr. Lewis has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Argenx. Dr. Lewis has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for CSL Behring. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Grifols. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Takeda. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Nuvig. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Dianthus. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Janssen. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Medscape. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Annexon. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunovant. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BioCryst. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NervoSave. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Annexon. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TGTX. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Boehringer-Ingleheim. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Intellia. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Cartesian. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for CME Outfitters. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PeerVision. Dr. Lewis has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Up to Date. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boehringer Ingelheim. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alnylam. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Intellia. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Shernoff et al. Dr. Lewis has received publishing royalties from a publication relating to health care.