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

NCT06858579 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: DNTH103-CIDP-3012024-517529-26
• Study Type: interventional
• Target: 256
• Locations: 27 countries
• Sites: 158

Brief Summary

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).

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Outcome Measures

Primary Outcomes (1)

• Part B: Time From First Dose to Relapse as Assessed by the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT)

  Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability. A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT score.

  Part B baseline to Part B end of treatment period (up to Week 52)

Secondary Outcomes (17)

• Part B: Time to Decrease of ≥ 4 Points (Centile Metric) in Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score

  Part B baseline to Part B end of treatment period (up to Week 52)

• Part B: Time to Decrease of ≥ 8 kilopascal (kPa) in Grip Strength in the Dominant Hand

  Part B baseline to Part B end of treatment period (up to Week 52)

• Part B: Percentage of Participants who Relapse as Assessed by the Adjusted INCAT

  Part B baseline to end of treatment period for Part B (up to Week 52)

• Parts A and B: Change in I-RODS Score (Centile Metric)

  Part A baseline up to Part A end of treatment period (up to Week 13); Part A baseline to Part B end of treatment period (up to Part B Week 52)

• Parts A and B: Change in Grip Strength in the Dominant Hand

  Part A baseline to Part A end of treatment period (up to Week 13); Part A baseline to Part B end of treatment period (up to Part B Week 52)

Study Arms (4)

Claseprubart (Part A)

EXPERIMENTAL

Claseprubart intravenous (IV) loading dose on Day 1. Claseprubart subcutaneous (SC) once every 2 weeks for up to 13 weeks.

Drug: Claseprubart

Claseprubart (Part B)

EXPERIMENTAL

Claseprubart SC once every 2 weeks for up to 52 weeks.

Drug: Claseprubart

Placebo (Part B)

PLACEBO COMPARATOR

Placebo SC once every 2 weeks for up to 52 weeks.

Drug: Placebo

Claseprubart (Optional OLE)

EXPERIMENTAL

Claseprubart SC once every 2 weeks for up to 104 weeks.

Drug: Claseprubart

Interventions

Placebo DRUG

SC injection

Placebo (Part B)

Claseprubart DRUG

IV Infusion

Also known as: DNTH103

Claseprubart (Part A)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.
• 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.
• Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.
• 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.
• 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.
• Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.

Sponsors & Collaborators

• Dianthus Therapeutics: lead

Study Sites (158)

Clinical Study Site

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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Clinical Study Site

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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Cinical Study Site

Lebanon, New Hampshire, 03766, 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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Clinical Study Site

Denton, Texas, 76208, United States

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Cinical Study Site

Houston, Texas, 77030, United States

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Texas Locations

Houston, Texas, 77054, United States

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Clinical Study Site

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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Cinical Study Site

Rosario, Santa Fe Province, Argentina

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Cinical Study Site #3

Buenos Aires, Argentina

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Cinical Study Site #4

Buenos Aires, Argentina

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Buenos Aires, Argentina

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Clinical Study Site #2

Buenos Aires, Argentina

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Buenos Aires, Argentina

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Cinical Study Site #2

San Miguel de Tucumán, Argentina

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San Miguel de Tucumán, Argentina

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Randwick, New South Wales, 2031, 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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Melbourne, Victoria, 3004, Australia

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Brussels, Belgium

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Campinas, São Paulo, Brazil

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Natal, Brazil

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Porto Alegre, 90610-000, Brazil

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Cinical Study Site

Rio de Janeiro, 20551-030, Brazil

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Cinical Study Site

Salvador, 40290-000, Brazil

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Cinical Study Site

São Paulo, 04038, Brazil

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Cinical Study Site

São Paulo, 05403-000, Brazil

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Sofia, Bulgaria

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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, 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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Cinical Study Site

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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Aarhus, 8200, Denmark

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Copenhagen, Denmark

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Bordeaux, 33000, France

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Brest, 29200, 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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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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Greifswald, 17489, Germany

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Rüdersdorf, 15562, Germany

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Sande, 26452, Germany

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Beersheba, Israel

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Haifa, 3109601, Israel

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Safed, Israel

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Bergamo, 24127, Italy

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Bologna, 40139, Italy

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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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Pavia, 27100, Italy

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Ponderano, 13875, Italy

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Roma, 00128, Italy

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Clinical Study Site #2

Roma, 00189, Italy

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Clinical Study Site

Roma, Italy

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Cinical Study Site

Terni, Italy

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Cinical Study Site

Riga, LV-1002, Latvia

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Riga, LV-1024, Latvia

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Cinical Study Site

Kota Kinabalu, Sabah, Malaysia

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Kuching, Sarawak, Malaysia

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George Town, 11700, Malaysia

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Cinical Study Site

Johor Bahru, 80100, Malaysia

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Cinical Study Site

Kota Kinabalu, Malaysia

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Cinical Study Site

Kuala Lumpur, 50586, Malaysia

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Cinical Study Site

Kuala Lumpur, 50603, Malaysia

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Cinical Study Site

Kuala Lumpur, 56000, Malaysia

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Kuching, Malaysia

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Cinical Study Site

Sungai Buloh, Malaysia

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Cinical Study Site

Utrecht, Netherlands

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Skopje, 1000, North Macedonia

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Cebu City, Philippines

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Iloilo City, Philippines

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Clinical Study Site

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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Cinical Study Site

Warsaw, 04-141, Poland

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Wroclaw, 50-367, Poland

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Clinical Study Site

Bucharest, 050474, Romania

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Belgrade, 11000, Serbia

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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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Cinical Study Site

Daegu, South Korea

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Daejeon, South Korea

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Cinical Study Site #2

Seoul, South Korea

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Cinical Study Site #3

Seoul, South Korea

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Seoul, South Korea

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Cinical Study Site

Yangsan, South Korea

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Clinical Study Site

Alicante, 03010, Spain

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Clinical Study Site

Barcelona, 08025, Spain

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Cinical Study Site

Barcelona, 08041, Spain

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Clinical Study Site

Barcelona, 08916, Spain

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Clinical Study Site

Bilbao, 48013, Spain

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Cinical Study Site #2

Bangkok, Thailand

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Cinical Study Site

Bangkok, Thailand

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Cinical Study Site

Hat Yai, Thailand

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Cinical Study Site

Khlong Luang, Thailand

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Cinical Study Site

Khon Kaen, 40002, Thailand

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Cinical Study Site

Khon Kaen, Thailand

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Clinical Study Site

Oxford, United Kingdom

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MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dianthus Clinical Contact Center

CONTACT

929-999-4055; clinicaltrials@dianthustx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 5, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); IL (3); CR (1); TH (6); CO (3); BE (1); PH (2); MY (10); KR (6); GE (1); LA (2); FR (12); US (30); DK (2); PL (7); RO (1); AR (8); NL (1); IT (13); AU (5); DE (5); SE (4); ES (5); GB (1); CN (19); BU (2); BR (7)