Dianthus Therapeutics Advances CAPTIVATE Phase 3 CIDP Trial

Company drops 600 mg arm, raises responder target after positive interim analysis

Mar. 15, 2026 at 12:49pm

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Dianthus Therapeutics announced it has made an 'early go' decision to continue its CAPTIVATE Phase 3 trial evaluating claseprubart in chronic inflammatory demyelinating polyneuropathy (CIDP), based on a planned interim responder analysis. The company is implementing several changes to the study design, including dropping the 600 mg arm and reducing overall enrollment, after reaching the upper end of its interim responder target.

Why it matters

CIDP is a rare autoimmune disorder that can lead to progressive weakness and impaired sensory function in the arms and legs. Effective treatments are limited, so a new therapy that demonstrates strong efficacy and safety could be a significant advancement for CIDP patients. Dianthus' ability to hit its interim responder target early and raise the bar suggests the drug candidate may have promising potential.

The details

In the CAPTIVATE trial's open-label Part A, patients receive claseprubart 300 mg subcutaneously every two weeks. To advance to the blinded Part B, patients must improve by at least one point on the NCAT score at two consecutive visits starting at week 5. Dianthus targeted an interim confirmed responder rate of 40-50% among the first 40 patients, and reached the upper end of that range before 40 patients completed Part A. Based on these results, the company is eliminating the 600 mg arm from Part B and raising the Part A responder target to 50%, which management says will provide stronger statistical power.

  • Dianthus expects to provide guidance later this year on when to anticipate CIDP top-line results.
  • The company plans to initiate a Phase 3 trial in generalized myasthenia gravis in mid-2026, with top-line results expected in the second half of 2028.
  • Top-line Phase 2 data from the MoMeNtum trial in multifocal motor neuropathy is expected in the second half of this year.

The players

Dianthus Therapeutics

A clinical-stage biotechnology company developing complement therapeutics for autoimmune and inflammatory diseases.

Dr. Simrat Randhawa

Dianthus' head of R&D.

Marino Garcia

Dianthus' Chief Executive Officer.

Ryan Savitz

Dianthus' Chief Financial and Business Officer.

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