Home › Trials › NCT06858579

Evaluating DNTH103 for treating chronic inflammatory demyelinating polyneuropathy

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)

PHASE3 · Dianthus Therapeutics · NCT06858579

This study is testing a new treatment called DNTH103 to see if it can help adults with chronic inflammatory demyelinating polyneuropathy feel better and stay safe.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment256 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorDianthus Therapeutics (industry)
Locations167 sites (Birmingham, Alabama and 166 other locations)
Trial IDNCT06858579 on ClinicalTrials.gov

What this trial studies

This Phase 3 study aims to assess the efficacy and safety of DNTH103 in adults diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP). The trial consists of an open-label period followed by a randomized, placebo-controlled phase for participants who respond positively to DNTH103. An optional open-label extension is available for eligible participants, allowing for continued treatment and monitoring. The study will also include a safety follow-up period to evaluate long-term effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of CIDP who have shown a response to previous immunoglobulin treatments.

Not a fit: Patients who do not have CIDP or those who are not neurologically stable may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from CIDP by providing a new effective therapy.

How similar studies have performed: Other studies have shown promise in treating CIDP with similar therapeutic approaches, indicating a potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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.
6. Must have an 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 are no longer being treated with (eg, lost access to), a maintenance regimen of Ig (IVIg or SCIg) alone or Ig (IVIg or SCIg) plus oral corticosteroids.
   2. Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.
   3. Refractory participants who have had treatment failure (worsening) or an inadequate response to Ig and/or oral corticosteroids (defined as no clinically meaningful improvement after a period of a minimum of 12 weeks, which may include both active treatment and observation to assess response), or who at any time were unable to tolerate these treatments, experienced adverse effects, or have documented contraindications.
   4. Treatment naïve with no history of prior treatment for CIDP.
8. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.
9. 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.
10. 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:

1. Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.
2. Known evidence of central demyelination or known history of myelopathy.
3. History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety/efficacy or study procedures.
4. Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.
5. Known complement deficiency or history of positive titer for anti-C1 antibodies.
6. Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).
7. Participants with an autoimmune disease affecting joints, muscle or nervous system.
8. Any coexisting or overlapping condition, which may interfere with outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis or osteoarthritis affecting the hands and feet.
9. Prior history of N. meningitidis infection.
10. History of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.
11. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.

Where this trial is running

Birmingham, Alabama and 166 other locations

+117 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.