New drug aims to stop CIDP relapses in its tracks

NCT ID NCT06858579

Disease control Sponsor: Dianthus Therapeutics Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 6 times

Summary

This Phase 3 trial tests whether the drug claseprubart (DNTH103) can prevent relapses in adults with CIDP, a nerve disorder that causes weakness and disability. About 256 participants will receive either the drug or a placebo. The main goal is to see how long it takes for symptoms to worsen, with a focus on safety and effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: claseprubart (DNTH103)
What this could lead to: If successful, this could provide a new treatment option to control CIDP and reduce relapses, helping patients maintain function and independence.
What could go wrong: This is still an experimental drug. Even in Phase 3, it may not prove better than placebo, and side effects are possible. Results may not apply to all CIDP patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 256 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic inflammatory demyelinating polyradiculoneuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic inflammatory demyelinating polyneuropathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

192 sites in 30 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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New Haven, Connecticut, 06520, United States
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Lebanon, New Hampshire, 03766, United States
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Nashville, Tennessee, 37232, United States
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Houston, Texas, 77030, United States
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Buenos Aires, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, Argentina
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Liverpool, New South Wales, Australia
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Saint Leonards, New South Wales, 2065, Australia
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Sydney, New South Wales, 2033, Australia
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Southport, Queensland, 4215, Australia
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Anderlecht, Brussels Capital, Belgium
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Brussels, Belgium
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Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil
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Natal, Brazil
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Porto Alegre, 90610-000, Brazil
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Salvador, 40290-000, Brazil
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São Paulo, 04038, Brazil
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São Paulo, 05403-000, Brazil
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São Paulo, Brazil
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Sofia, Bulgaria
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Medellín, Antioquia, Colombia
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Antioquia, Colombia
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Medellín, Colombia
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Osijek, Croatia
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Brest, 29200, France
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Tours, 37000, France
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München, Bavaria, Germany
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Greifswald, 17489, Germany
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Beersheba, Israel
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Haifa, 3109601, Israel
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Safed, Israel
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Genova, 16132, Italy
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Gussago, 25064, Italy
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Milan, 20126, Italy
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Milan, Italy
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Modena, Italy
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Roma, 00133, Italy
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Salerno, 84131, Italy
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Terni, Italy
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Niigata, Chubu, Japan
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Kawasaki, Kanto, Japan
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Tsukuba, Kanto, Japan
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Kurashiki, Okayama-ken, 701-0192, Japan
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Hirakata, Osaka, Japan
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Kawagoe, Saitama, Japan
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Ube, Yamaguchi, 755-0046, Japan
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Riga, LV-1002, Latvia
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Kota Kinabalu, Sabah, Malaysia
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Serdang, Salangor, Malaysia
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Kuching, Sarawak, Malaysia
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George Town, 11700, Malaysia
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Johor Bahru, 80100, Malaysia
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Kota Kinabalu, Malaysia
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Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, 50603, Malaysia
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Kuala Lumpur, 56000, Malaysia
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Kuching, Malaysia
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Serdang, 43400, Malaysia
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Sungai Buloh, Malaysia
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Amsterdam, Netherlands
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Utrecht, Netherlands
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Batangas, Philippines
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Cebu City, Philippines
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City of Muntinlupa, Philippines
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Iloilo City, Philippines
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Lodz, 90-324, Poland
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Warsaw, 04-141, Poland
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Târgu Mureş, 540136, Romania
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Belgrade, 11000, Serbia
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Daegu, South Korea
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Daejeon, South Korea
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Seoul, South Korea
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Uijeongbu-si, South Korea
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Yangsan, South Korea
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Barcelona, 08041, Spain
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Bangkok, 10400, Thailand
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Bangkok, Thailand
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Chiang Mai, 50200, Thailand
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Hat Yai, Thailand
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Khlong Luang, Thailand
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Khon Kaen, 40002, Thailand
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Khon Kaen, Thailand
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Ankara, 06230, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)
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Manchester, England, United Kingdom
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Hanoi, Vietnam
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San Miguel de Tucumán, Argentina
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Seoul, South Korea
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Bangkok, Thailand
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Hanoi, Vietnam
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Buenos Aires, Argentina
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Seoul, South Korea
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Buenos Aires, Argentina
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Birmingham, Alabama, 35294, United States
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Phoenix, Arizona, 85028, United States
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Scottsdale, Arizona, 85251', United States
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Los Angeles, California, 90048, United States
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San Francisco, California, 94109, United States
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San Francisco, California, 94158, United States
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Washington D.C., District of Columbia, 20007, United States
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Maitland, Florida, 32751, United States
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Tampa, Florida, 33620, United States
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Honolulu, Hawaii, 96817, United States
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Chicago, Illinois, 60611, United States
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Edwardsville, Illinois, 62025, United States
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Indianapolis, Indiana, 46202, United States
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Kansas City, Kansas, 66160, United States
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Burlington, Massachusetts, 01805, United States
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East Lansing, Michigan, 48824, United States
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Omaha, Nebraska, 68198, United States
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New York, New York, 10021, United States
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New York, New York, 10032, United States
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Cincinnati, Ohio, 45219, United States
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Columbus, Ohio, 43221, United States
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Portland, Oregon, 97239, United States
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Dallas, Texas, 75243, United States
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Denton, Texas, 76208, United States
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Round Rock, Texas, 78681, United States
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Sugar Land, Texas, 77478, United States
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Seattle, Washington, 98195, United States
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Buenos Aires, Argentina
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San Miguel de Tucumán, Argentina
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Randwick, New South Wales, 2031, Australia
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Melbourne, Victoria, 3004, Australia
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Campinas, São Paulo, Brazil
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Sofia, Bulgaria
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Hefei, Anhui, 230001, China
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Guangzhou, Guangdong, 510080, China
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Changsha, Hu'Nan, 410008, China
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Changsha, Hu'Nan, 410013, China
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Wuhan, Hubei, 430060, China
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Chifeng, Inner Mongolia, 024050, China
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Suzhou, Jiangsu, 215006, China
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Beijing, 100034, China
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Beijing, 100191, China
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Chengdu, 610072, China
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Fujian, 350001, China
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Guangdong, 510180, China
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Guangzhou, 510515, China
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Jilin City, 130021, China
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Shanghai, 200031, China
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Shanghai, 200040, China
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Sichuan, 610072, China
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Taiyuan, China
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Wuhan, China
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Aarhus, 8200, Denmark
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Copenhagen, Denmark
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Bordeaux, 33000, France
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Bron, 69500, France
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Clermont-Ferrand, 63000, France
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Libourne, 33500, France
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Marseille, 13005, France
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Nice, 06000, France
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Paris, 75013, France
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Paris, 75610, France
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Strasbourg, 67200, France
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Tours, 37000, France
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Tbilisi, Georgia
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Sande, Lower Saxony, 26452, Germany
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Aachen, 52074, Germany
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Rüdersdorf, 15562, Germany
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Sande, 26452, Germany
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Bergamo, 24127, Italy
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Bologna, 40139, Italy
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Monza, 20900, Italy
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Pavia, 27100, Italy
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Ponderano, 13875, Italy
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Roma, 00128, Italy
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Roma, Italy
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Riga, LV-1024, Latvia
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Skopje, 1000, North Macedonia
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Bydgoszcz, 85-090, Poland
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Krakow, 30-688, Poland
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Lublin, 20-701, Poland
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Lublin, 20-718, Poland
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Lublin, 7763138, Poland
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Wroclaw, 50-367, Poland
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Bucharest, 050474, Romania
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Belgrade, 11000, Serbia
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Kragujevac, 34000, Serbia
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Niš, 18000, Serbia
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Barcelona, Barcelona, 08916, Spain
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Alicante, 03010, Spain
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Barcelona, 08025, Spain
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Bilbao, 48013, Spain
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Oxford, United Kingdom
Clinical Study Site #2
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Buenos Aires, Argentina
Clinical Study Site #2
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Roma, 00189, Italy
Texas Locations
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Houston, Texas, 77054, United States

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