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Looking for participantsPhase3

A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)

Sponsor: Dianthus Therapeutics

NCT ID: NCT06858579

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Claseprubart (drug), Claseprubart (drug), Placebo (drug)
How long the study runs
Study runs about 70 months (dates as stated)
About the drug or intervention
Claseprubart — drug: IV Infusion · Claseprubart — drug: SC injection · Placebo — drug: SC injection
Patient visit burden
Not specified by the sponsor

In plain English

This study, called CAPTIVATE, is testing a medicine called DNTH103 in adults with chronic inflammatory demyelinating polyneuropathy (CIDP), a condition where the immune system damages nerves and causes weakness or numbness. The researchers want to find out how well the medicine works and how safe it is. The study is funded by Dianthus Therapeutics.

Who can take part

  • Adults with confirmed CIDP, or possible CIDP, including the motor or multifocal types. Diagnosis must be confirmed by an independent review panel
  • Weigh between 40 kg and 120 kg
  • Neurologically stable, with a disease activity score (CDAS) of 3 or more at screening and an INCAT disability score between 2 and 9
  • Must fit one of these treatment situations: currently on or previously responded to immunoglobulin treatment (given through a vein or under the skin), with or without steroid tablets; on steroid tablets alone or with azathioprine or mycophenolate mofetil; have not improved on or cannot tolerate these treatments; or have never had treatment for CIDP
  • Have had the recommended vaccinations against encapsulated bacteria, where available
  • Women must be unable to become pregnant or agree not to try, not donate eggs, and use highly effective contraception if sexually active with a male partner
  • Men must agree not to donate sperm and to use contraception or be surgically sterile, if their partner could become pregnant
  • Must give written informed consent before any study activities

Who may not be able to

  • Signs of nerve damage (polyneuropathy) caused by something other than CIDP
  • Evidence of damage to the brain or spinal cord nerves (central demyelination) or a history of myelopathy
  • A significant medical or surgical condition, acute illness or major surgery that could affect safety or the study results
  • Any other condition, including mental illness or past treatment, that would make taking part unsuitable
  • Known complement deficiency or a history of positive anti-C1 antibody tests
  • Systemic lupus erythematosus (SLE), or a parent, sibling or child who has had it
  • Another autoimmune disease affecting the joints, muscles or nervous system
  • A condition that could interfere with the results, such as severe diabetic nerve damage, fibromyalgia, inflammatory arthritis or arthritis in the hands and feet
  • Previous infection with N. meningitidis (a type of bacteria causing meningitis)
  • Cancer within the past 5 years, except certain treated skin cancers, treated cervical cancer in situ, or low-grade prostate cancer being watched without treatment
  • Positive test results for HIV, hepatitis B surface antigen, or hepatitis C antibodies

What taking part involves

  • • Taking the study medicine DNTH103
  • • Not stated in detail — ask the trial team about how the medicine is given, the dose, and whether there is a comparison (placebo) group

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 75 Years
Who
All
Number of participants
256
Started
2025-02-10
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic inflammatory demyelinating polyneuropathy
  • • Phase3 - 256 participants
  • • The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP)

Who can take part?

  • • Ages 18 Years to 75 Years
  • • Diagnosed with chronic inflammatory demyelinating polyneuropathy

Where?

  • • Manchester - Cinical Study Site
  • • Oxford - Clinical Study Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).

More detail

The study includes the following periods: * Part A: An open-label period (up to 13 weeks) * Part B: A randomized, placebo-controlled, double-blind treatment period (up to 52 weeks) for participants who respond to DNTH103 in Part A * Optional open-label extension (OLE) for eligible participants (up to 104 weeks) * Safety follow-up (40 weeks)

Chronic Inflammatory Demyelinating Polyneuropathy

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 75 Years
  • Who can join: All genders

Biomarkers mentioned

history of positive

Treatment history

Treatments you must have had:

  • ✓ given written informed consent
  • ✓ either typical CIDP or one of the following variants: motor or multifocal CIDP
  • ✓ an INCAT score between 2 and 9 inclusive

What the study is looking for

  • ✓Must have given written agreement to take part before any study-related activities are carried out.
  • ✓Weight range between 40 kilograms (kg) and 120 kg.
  • ✓CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.
  • ✓Must be neurologically stable.
  • ✓Must have an INCAT score between 2 and 9 inclusive.

Who cannot take part

  • ✗Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.
  • ✗Known evidence of central demyelination or known history of myelopathy.
  • ✗Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this...
  • ✗Known complement deficiency or history of positive titer for anti-C1 antibodies.
  • ✗Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).
See the full 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 Is This Study? (2 UK sites)

Cinical Study Site

Manchester, United Kingdom

Recruiting

Clinical Study Site

Oxford, United Kingdom

Recruiting

How to Get in Touch

Dianthus Clinical Contact Center

Sponsor contact

CONTACT

929-999-4055 clinicaltrials@dianthustx.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04