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

May 12, 2026 updated by: Dianthus Therapeutics

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).

Study Overview

Status

Recruiting

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Estimated)

256

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Dianthus Clinical Contact Center
Phone Number: 929-999-4055
Email: clinicaltrials@dianthustx.com

Study Locations

Argentina
- - Buenos Aires, Argentina
    - Recruiting
    - Clinical Study Site #2
  - Buenos Aires, Argentina
    - Recruiting
    - Clinical Study Site
  - Buenos Aires, Argentina
    - Recruiting
    - Cinical Study Site #3
  - Buenos Aires, Argentina
    - Recruiting
    - Cinical Study Site #4
  - San Miguel de Tucumán, Argentina
    - Recruiting
    - Clinical Study Site
  - San Miguel de Tucumán, Argentina
    - Recruiting
    - Cinical Study Site #2
- Buenos Aires
  - Buenos Aires, Buenos Aires, Argentina
    - Recruiting
    - Cinical Study Site
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina
    - Recruiting
    - Cinical Study Site
Australia
- New South Wales
  - Liverpool, New South Wales, Australia
    - Recruiting
    - Cinical Study Site
  - Randwick, New South Wales, Australia, 2031
    - Recruiting
    - Clinical Study Site
  - Saint Leonards, New South Wales, Australia, 2065
    - Recruiting
    - Cinical Study Site
  - Sydney, New South Wales, Australia, 2033
    - Recruiting
    - Cinical Study Site
- Queensland
  - Southport, Queensland, Australia, 4215
    - Recruiting
    - Cinical Study Site
- Victoria
  - Melbourne, Victoria, Australia, 3004
    - Recruiting
    - Clinical Study Site
Belgium
- - Brussels, Belgium
    - Recruiting
    - Cinical Study Site
- Brussels Capital
  - Anderlecht, Brussels Capital, Belgium
    - Recruiting
    - Cinical Study Site
Brazil
- - Natal, Brazil
    - Recruiting
    - Cinical Study Site
  - Porto Alegre, Brazil, 90610-000
    - Recruiting
    - Cinical Study Site
  - Salvador, Brazil, 40290-000
    - Recruiting
    - Cinical Study Site
  - São Paulo, Brazil, 04038
    - Recruiting
    - Cinical Study Site
  - São Paulo, Brazil, 05403-000
    - Recruiting
    - Cinical Study Site
- Rio de Janeiro
  - Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
    - Recruiting
    - Cinical Study Site
- São Paulo
  - Campinas, São Paulo, Brazil
    - Recruiting
    - Clinical Study Site
Bulgaria
- - Sofia, Bulgaria
    - Recruiting
    - Clinical Study Site
  - Sofia, Bulgaria
    - Recruiting
    - Cinical Study Site
China
- - Beijing, China, 100191
    - Recruiting
    - Clinical Study Site
  - Beijing, China, 100034
    - Recruiting
    - Clinical Study Site
  - Chengdu, China, 610072
    - Recruiting
    - Clinical Study Site
  - Fujian, China, 350001
    - Recruiting
    - Clinical Study Site
  - Guangdong, China, 510180
    - Recruiting
    - Clinical Study Site
  - Guangzhou, China, 510515
    - Recruiting
    - Clinical Study Site
  - Jilin, China, 130021
    - Recruiting
    - Clinical Study Site
  - Shanghai, China, 200031
    - Recruiting
    - Clinical Study Site
  - Shanghai, China, 200040
    - Recruiting
    - Clinical Study Site
  - Sichuan, China, 610072
    - Recruiting
    - Clinical Study Site
  - Taiyuan, China
    - Recruiting
    - Clinical Study Site
  - Wuhan, China
    - Recruiting
    - Clinical Study Site
- Anhui
  - Hefei, Anhui, China, 230001
    - Recruiting
    - Clinical Study Site
- Guangdong
  - Guangzhou, Guangdong, China, 510080
    - Recruiting
    - Clinical Study Site
- Hu'Nan
  - Changsha, Hu'Nan, China, 410008
    - Recruiting
    - Clinical Study Site
  - Changsha, Hu'Nan, China, 410013
    - Recruiting
    - Clinical Study Site
- Hubei
  - Wuhan, Hubei, China, 430060
    - Recruiting
    - Clinical Study Site
- Inner Mongolia
  - Chifeng, Inner Mongolia, China, 024050
    - Recruiting
    - Clinical Study Site
- Jiangsu
  - Suzhou, Jiangsu, China, 215006
    - Recruiting
    - Clinical Study Site
Colombia
- - Antioquia, Colombia
    - Recruiting
    - Cinical Study Site
  - Medellín, Colombia
    - Recruiting
    - Cinical Study Site
- Antioquia
  - Medellín, Antioquia, Colombia
    - Recruiting
    - Cinical Study Site
Croatia
- - Osijek, Croatia
    - Recruiting
    - Cinical Study Site
Denmark
- - Aarhus, Denmark, 8200
    - Recruiting
    - Clinical Study Site
  - Copenhagen, Denmark
    - Recruiting
    - Clinical Study Site
France
- - Bordeaux, France, 33000
    - Recruiting
    - Clinical Study Site
  - Brest, France, 29200
    - Recruiting
    - Cinical Study Site
  - Bron, France, 69500
    - Recruiting
    - Clinical Study Site
  - Clermont-Ferrand, France, 63000
    - Recruiting
    - Clinical Study Site
  - Libourne, France, 33500
    - Recruiting
    - Clinical Study Site
  - Marseille, France, 13005
    - Recruiting
    - Clinical Study Site
  - Nice, France, 06000
    - Recruiting
    - Clinical Study Site
  - Paris, France, 75013
    - Recruiting
    - Clinical Study Site
  - Paris, France, 75610
    - Recruiting
    - Clinical Study Site
  - Strasbourg, France, 67200
    - Recruiting
    - Clinical Study Site
  - Tours, France, 37000
    - Recruiting
    - Clinical Study Site
  - Tours, France, 37000
    - Recruiting
    - Cinical Study Site
Georgia
- - Tbilisi, Georgia
    - Recruiting
    - Clinical Study Site
Germany
- - Aachen, Germany, 52074
    - Recruiting
    - Clinical Study Site
  - Greifswald, Germany, 17489
    - Recruiting
    - Cinical Study Site
  - Rüdersdorf, Germany, 15562
    - Recruiting
    - Clinical Study Site
  - Sande, Germany, 26452
    - Recruiting
    - Clinical Study Site
- Bavaria
  - München, Bavaria, Germany
    - Recruiting
    - Cinical Study Site
- Lower Saxony
  - Sande, Lower Saxony, Germany, 26452
    - Recruiting
    - Clinical Study Site
Israel
- - Beersheba, Israel
    - Recruiting
    - Cinical Study Site
  - Haifa, Israel, 3109601
    - Recruiting
    - Cinical Study Site
  - Safed, Israel
    - Recruiting
    - Cinical Study Site
Italy
- - Bergamo, Italy, 24127
    - Recruiting
    - Clinical Study Site
  - Bologna, Italy, 40139
    - Recruiting
    - Clinical Study Site
  - Genova, Italy, 16132
    - Recruiting
    - Cinical Study Site
  - Gussago, Italy, 25064
    - Recruiting
    - Cinical Study Site
  - Milan, Italy, 20126
    - Recruiting
    - Cinical Study Site
  - Milan, Italy
    - Recruiting
    - Cinical Study Site
  - Modena, Italy
    - Recruiting
    - Cinical Study Site
  - Pavia, Italy, 27100
    - Recruiting
    - Clinical Study Site
  - Ponderano, Italy, 13875
    - Recruiting
    - Clinical Study Site
  - Roma, Italy, 00189
    - Recruiting
    - Clinical Study Site #2
  - Roma, Italy
    - Recruiting
    - Clinical Study Site
  - Roma, Italy, 00128
    - Recruiting
    - Clinical Study Site
  - Roma, Italy, 00133
    - Recruiting
    - Cinical Study Site
  - Terni, Italy
    - Recruiting
    - Cinical Study Site
Latvia
- - Riga, Latvia, LV-1024
    - Recruiting
    - Clinical Study Site
  - Riga, Latvia, LV-1002
    - Recruiting
    - Cinical Study Site
Malaysia
- - George Town, Malaysia, 11700
    - Recruiting
    - Cinical Study Site
  - Johor Bahru, Malaysia, 80100
    - Recruiting
    - Cinical Study Site
  - Kota Kinabalu, Malaysia
    - Recruiting
    - Cinical Study Site
  - Kuala Lumpur, Malaysia, 50586
    - Recruiting
    - Cinical Study Site
  - Kuala Lumpur, Malaysia, 50603
    - Recruiting
    - Cinical Study Site
  - Kuala Lumpur, Malaysia, 56000
    - Recruiting
    - Cinical Study Site
  - Kuching, Malaysia
    - Recruiting
    - Cinical Study Site
  - Sungai Buloh, Malaysia
    - Recruiting
    - Cinical Study Site
- Sabah
  - Kota Kinabalu, Sabah, Malaysia
    - Recruiting
    - Cinical Study Site
- Sarawak
  - Kuching, Sarawak, Malaysia
    - Recruiting
    - Cinical Study Site
Netherlands
- - Amsterdam, Netherlands
    - Recruiting
    - Cinical Study Site
  - Utrecht, Netherlands
    - Recruiting
    - Cinical Study Site
North Macedonia
- - Skopje, North Macedonia, 1000
    - Recruiting
    - Clinical Study Site
Philippines
- - Cebu City, Philippines
    - Recruiting
    - Cinical Study Site
  - City of Muntinlupa, Philippines
    - Recruiting
    - Cinical Study Site
  - Iloilo City, Philippines
    - Recruiting
    - Cinical Study Site
Poland
- - Bydgoszcz, Poland, 85-090
    - Recruiting
    - Clinical Study Site
  - Krakow, Poland, 30-688
    - Recruiting
    - Clinical Study Site
  - Lublin, Poland, 7763138
    - Recruiting
    - Clinical Study Site
  - Lublin, Poland, 20-701
    - Recruiting
    - Clinical Study Site
  - Lublin, Poland, 20-718
    - Recruiting
    - Clinical Study Site
  - Warsaw, Poland, 04-141
    - Recruiting
    - Cinical Study Site
  - Wroclaw, Poland, 50-367
    - Recruiting
    - Clinical Study Site
Romania
- - Bucharest, Romania, 050474
    - Recruiting
    - Clinical Study Site
  - Târgu Mureş, Romania, 540136
    - Recruiting
    - Cinical Study Site
Serbia
- - Belgrade, Serbia, 11000
    - Recruiting
    - Clinical Study Site
  - Belgrade, Serbia, 11000
    - Recruiting
    - Cinical Study Site
  - Kragujevac, Serbia, 34000
    - Recruiting
    - Clinical Study Site
  - Niš, Serbia, 18000
    - Recruiting
    - Clinical Study Site
South Korea
- - Daegu, South Korea
    - Recruiting
    - Cinical Study Site
  - Daejeon, South Korea
    - Recruiting
    - Cinical Study Site
  - Seoul, South Korea
    - Recruiting
    - Cinical Study Site #2
  - Seoul, South Korea
    - Recruiting
    - Cinical Study Site #3
  - Seoul, South Korea
    - Recruiting
    - Cinical Study Site
  - Uijeongbu-si, South Korea
    - Recruiting
    - Cinical Study Site
  - Yangsan, South Korea
    - Recruiting
    - Cinical Study Site
Spain
- - Alicante, Spain, 03010
    - Recruiting
    - Clinical Study Site
  - Barcelona, Spain, 08025
    - Recruiting
    - Clinical Study Site
  - Barcelona, Spain, 08041
    - Recruiting
    - Cinical Study Site
  - Bilbao, Spain, 48013
    - Recruiting
    - Clinical Study Site
- Barcelona
  - Barcelona, Barcelona, Spain, 08916
    - Recruiting
    - Clinical Study Site
Thailand
- - Bangkok, Thailand
    - Recruiting
    - Cinical Study Site #2
  - Bangkok, Thailand
    - Recruiting
    - Cinical Study Site
  - Hat Yai, Thailand
    - Recruiting
    - Cinical Study Site
  - Khlong Luang, Thailand
    - Recruiting
    - Cinical Study Site
  - Khon Kaen, Thailand, 40002
    - Recruiting
    - Cinical Study Site
  - Khon Kaen, Thailand
    - Recruiting
    - Cinical Study Site
United Kingdom
- - Oxford, United Kingdom
    - Recruiting
    - Clinical Study Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - Recruiting
    - Clinical Study Site
- Arizona
  - Phoenix, Arizona, United States, 85028
    - Recruiting
    - Clinical Study Site
  - Scottsdale, Arizona, United States, 85251'
    - Recruiting
    - Clinical Study Site
- California
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Clinical Study Site
  - San Francisco, California, United States, 94109
    - Recruiting
    - Clinical Study Site
  - San Francisco, California, United States, 94158
    - Recruiting
    - Clinical Study Site
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Recruiting
    - Clinical Study Site
- Florida
  - Maitland, Florida, United States, 32751
    - Recruiting
    - Clinical Study Site
  - Tampa, Florida, United States, 33620
    - Recruiting
    - Clinical Study Site
- Hawaii
  - Honolulu, Hawaii, United States, 96817
    - Recruiting
    - Clinical Study Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Clinical Study Site
  - Edwardsville, Illinois, United States, 62025
    - Recruiting
    - Clinical Study Site
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Recruiting
    - Clinical Study Site
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Recruiting
    - Clinical Study Site
- Massachusetts
  - Burlington, Massachusetts, United States, 01805
    - Recruiting
    - Clinical Study Site
- Michigan
  - East Lansing, Michigan, United States, 48824
    - Recruiting
    - Clinical Study Site
- Nebraska
  - Omaha, Nebraska, United States, 68198
    - Recruiting
    - Clinical Study Site
- New Hampshire
  - Lebanon, New Hampshire, United States, 03766
    - Recruiting
    - Cinical Study Site
- New York
  - New York, New York, United States, 10032
    - Recruiting
    - Clinical Study Site
  - New York, New York, United States, 10021
    - Recruiting
    - Clinical Study Site
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Recruiting
    - Clinical Study Site
  - Columbus, Ohio, United States, 43221
    - Recruiting
    - Clinical Study Site
- Oregon
  - Portland, Oregon, United States, 97239
    - Recruiting
    - Clinical Study Site
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Cinical Study Site
- Texas
  - Dallas, Texas, United States, 75243
    - Recruiting
    - Clinical Study Site
  - Denton, Texas, United States, 76208
    - Recruiting
    - Clinical Study Site
  - Houston, Texas, United States, 77054
    - Recruiting
    - Texas Locations
  - Houston, Texas, United States, 77030
    - Recruiting
    - Cinical Study Site
  - Round Rock, Texas, United States, 78681
    - Recruiting
    - Clinical Study Site
  - Sugar Land, Texas, United States, 77478
    - Recruiting
    - Clinical Study Site
- Washington
  - Seattle, Washington, United States, 98195
    - Recruiting
    - Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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:
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.
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 Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (Part B) Placebo SC once every 2 weeks for up to 52 weeks.	Drug: Placebo SC injection
Experimental: Claseprubart (Part A) Claseprubart intravenous (IV) loading dose on Day 1. Claseprubart subcutaneous (SC) once every 2 weeks for up to 13 weeks.	Drug: Claseprubart IV Infusion Other Names: DNTH103 Drug: Claseprubart SC injection Other Names: DNTH103
Experimental: Claseprubart (Part B) Claseprubart SC once every 2 weeks for up to 52 weeks.	Drug: Claseprubart IV Infusion Other Names: DNTH103 Drug: Claseprubart SC injection Other Names: DNTH103
Experimental: Claseprubart (Optional OLE) Claseprubart SC once every 2 weeks for up to 104 weeks.	Drug: Claseprubart IV Infusion Other Names: DNTH103 Drug: Claseprubart SC injection Other Names: DNTH103

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part B: Time From First Dose to Relapse as Assessed by the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Time Frame: Part B baseline to Part B end of treatment period (up to Week 52)	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 Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dianthus Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

DNTH103-CIDP-301
2024-517529-26 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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West Penn Allegheny Health System

Completed

Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis

Asthma | Allergic Rhinitis

United States

Outcome Measure	Measure Description	Time Frame
Part B: Percentage of Participants who Relapse as Assessed by the Adjusted INCAT Time Frame: Part B baseline to end of treatment period for Part B (up to Week 52)	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 end of treatment period for Part B (up to Week 52)
Parts A and B: Change in Grip Strength in the Dominant Hand Time Frame: 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)	This is measured with a handheld device called a vigorimeter.	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)
Parts A and B: Change in Adjusted INCAT Score Time Frame: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)	Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability.	Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); 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 Nondominant Hand Time Frame: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)	This is measured with a handheld device called a vigorimeter.	Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B: Change in Medical Research Council Sum Score (MRC-SS) Time Frame: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)	The MRC-SS ranges from 0 to 60 with a lower score indicating greater muscle weakness.	Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Part A: Percentage of Participants with a Confirmed Response to DNTH103 as Assessed by the Adjusted INCAT Time Frame: Part A baseline to Part A end of treatment period (up to Week 13)	Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability. A response is defined as a decrease of ≥1 point from baseline in adjusted INCAT score.	Part A baseline to Part A end of treatment period (up to Week 13)
Parts A and B: Change in Euro-Quality of Life Visual Analogue Scale (EQ-VAS) Time Frame: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)	Participants mark their health status from 0 to 100 with 100 indicating the best health state.	Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B: Change in Fatigue Severity Scale (FSS) Time Frame: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)	FSS assesses disabling fatigue in participants with chronic illness.	Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)
Parts A and B and OLE: Change in Adjusted INCAT Score Time Frame: Part A baseline to OLE Week 52 and Week 104; Part B baseline to OLE Week 52 and Week 104; OLE baseline to OLE Week 52 and Week 104	Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability.	Part A baseline to OLE Week 52 and Week 104; Part B baseline to OLE Week 52 and Week 104; OLE baseline to OLE Week 52 and Week 104
Part B and OLE: Percentage of Participants With a Confirmed Relapse as Assessed by the Adjusted INCAT Time Frame: Part B baseline to OLE Week 52 and Week 104; OLE baseline to OLE Week 52 and Week 104	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 OLE Week 52 and Week 104; OLE baseline to OLE Week 52 and Week 104
Parts A, B, OLE, and Safety Follow-up: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) Time Frame: Part A baseline through Safety Follow-up period (up to approximately 209 weeks)	An adverse event (AE) is any undesirable experience associated with the use of a medicine, which does not necessarily have a causal relationship with the medicine. A TEAE is an AE with onset after the start of the medicine, or any worsening of a pre-existing medical condition/AE after the start of the medicine. An SAE is an AE that can cause disability, is life-threatening, results in hospitalization or death, or is a birth defect.	Part A baseline through Safety Follow-up period (up to approximately 209 weeks)
Parts A, B, OLE, and Safety Follow-up: Serum Concentrations of DNTH103 Time Frame: Part A baseline through Safety Follow-up period (up to approximately 209 weeks)	Blood samples will be collected for measurement of serum concentrations of DNTH103 at various timepoints both pre- and post-dose.	Part A baseline through Safety Follow-up period (up to approximately 209 weeks)
Parts A, B, and OLE: Change from Baseline in Complement Total Blood Test (CH50) Time Frame: Part A baseline through Safety Follow-up period (up to approximately 209 weeks)	Blood samples will be collected to determine changes in CH50 at various timepoints.	Part A baseline through Safety Follow-up period (up to approximately 209 weeks)
Parts A, B, OLE, and Safety Follow-up: Incidence and Titer of Antidrug Antibodies (ADAs) Time Frame: Part A baseline through Safety Follow-up period (up to approximately 209 weeks)	Blood samples will be collected to measure ADA against DNTH103 at various timepoints.	Part A baseline through Safety Follow-up period (up to approximately 209 weeks)
Part B: Time to Decrease of ≥ 4 Points (Centile Metric) in Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score Time Frame: Part B baseline to Part B end of treatment period (up to Week 52)	The I-RODS score ranges from 0-100, with lower scores indicating the greatest degree of disability.	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 Time Frame: Part B baseline to Part B end of treatment period (up to Week 52)	This is measured with a handheld device called a vigorimeter.	Part B baseline to Part B end of treatment period (up to Week 52)
Parts A and B: Change in I-RODS Score (Centile Metric) Time Frame: 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)	The I-RODS score ranges from 0-100, with lower scores indicating the greatest degree of disability.	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)

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

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)

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