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)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (2 UK sites)
Cinical Study Site
Manchester, United Kingdom
Clinical Study Site
Oxford, United Kingdom
How to Get in Touch
Dianthus Clinical Contact Center
Sponsor contactCONTACT
