Tests claseprubart against placebo for chronic inflammatory demyelinating polyneuropathy
Tests claseprubart compared with placebo in adults with chronic nerve inflammation disease.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)
Key facts
- Where
- Buenos Aires, Rosario, and San Miguel de Tucumán, ArgentinaSee the 8 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic inflammatory demyelinating polyneuropathy (CIDP), a nerve disease. Some have had treatment before, some have not.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Confirmed CIDP or possible CIDP, either typical CIDP or motor or multifocal CIDP. A CDAS score of 3 or more and an INCAT score of 2 to 9. Must be neurologically stable.
- Earlier treatment
- Must meet one of these: treated with and responded to immunoglobulin, with or without oral corticosteroids; treated with and responded to oral corticosteroids, alone or with azathioprine or mycophenolate mofetil; treatment did not work or was not tolerated; or never treated for CIDP.
Main reasons for not taking part
- Nerve disease caused by something other than CIDP
- Known complement deficiency or positive anti-C1 antibodies
- Lupus (SLE), or lupus in a parent, sibling or child
- Active HIV, hepatitis B or hepatitis C infection
- Cancer within the last 5 years, with a few exceptions
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06858579, who can take part
Where in Argentina
- Buenos AiresHospital not named in the registryTaking people
- Buenos AiresHospital not named in the registryTaking people
- Buenos AiresHospital not named in the registryTaking people
- Buenos AiresHospital not named in the registryTaking people
- Buenos AiresHospital not named in the registryTaking people
- Rosario, Santa Fe ProvinceHospital not named in the registryTaking people
- San Miguel de Tucumán, Tucumán ProvinceHospital not named in the registryTaking people
- San Miguel de TucumánHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Dianthus Therapeutics
- Trial code
- NCT06858579
- Record updated
- 28 October 2026
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: Must have given written informed consent before any study-related activities are carried out; Weight range between 40 kilograms (kg) and 120 kg; 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; CIDP Disease Activity Status (CDAS) score ≥ 3 at screening; Must be neurologically stable; Must have an INCAT score between 2 and 9 inclusive; Must fulfill one of the following treatment conditions for CIDP:; 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; Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil; 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; Treatment naïve with no history of prior treatment for CIDP; Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability; 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; 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: Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study; Prior history of N. meningitidis infection; 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; Known evidence of central demyelination or known history of myelopathy; 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; 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); Participants with an autoimmune disease affecting joints, muscle or nervous system; 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; Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies; Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.