NCT06858579 · Dianthus Therapeutics
A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)
(CAPTIVATE)
What this study is about
The purpose of this Phase 3 study is to demonstrate the effectiveness of DNTH103 as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).
View original scientific description
The purpose of this Phase 3 study is to demonstrate the efficacy of DNTH103 as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).
Interventions
DRUG
Claseprubart
IV Infusion
DRUG
Claseprubart
SC injection
DRUG
Placebo
SC injection
Primary outcome measures
Part B: Time From First Dose to Relapse as Assessed by the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT)
Time frame: Part B baseline to Part B end of treatment period (up to Week 52)
Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability. A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT score.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Must have given written informed consent before any study-related activities are carried out. 2. Weight range between 40 kilograms (kg) and 120 kg. 3. 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. 4. CIDP Disease Activity Status (CDAS) score ≥ 3 at screening. 5. Must be neurologically stable (ie, no relapses or other neurological events that could affect examinations). 6. Must have an adjusted INCAT score between 2 and 9 inclusive. 7. Must fulfill one of the following treatment conditions for CIDP: 1. Currently treated with and responded to immunoglobulin (Ig) (intravenous immunoglobulin \[IVIg\] or subcutaneous immunoglobulin \[SCIg\]) alone or Ig (IVIg or SCIg) plus oral corticosteroids, or previously treated with and responded to, but either no longer have access to or are no longer being
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Scottsdale, Arizona
- Los Angeles, California
- San Francisco, California
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Maitland, Florida
- Tampa, Florida
- Honolulu, Hawaii
- Chicago, Illinois
- Edwardsville, Illinois
And 17 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations