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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Part B: Time From First Dose to Relapse as Assessed by the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) — 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.
Trial sites (192)
Facility
City
Region
Status
Clinical Study Site
Birmingham
Alabama
Recruiting
Clinical Study Site
Phoenix
Arizona
Recruiting
Clinical Study Site
Scottsdale
Arizona
Recruiting
Clinical Study Site
Los Angeles
California
Recruiting
Clinical Study Site
San Francisco
California
Recruiting
Clinical Study Site
San Francisco
California
Recruiting
Cinical Study Site
New Haven
Connecticut
Recruiting
Clinical Study Site
Washington D.C.
District of Columbia
Recruiting
Clinical Study Site
Maitland
Florida
Recruiting
Clinical Study Site
Tampa
Florida
Recruiting
Clinical Study Site
Honolulu
Hawaii
Recruiting
Clinical Study Site
Chicago
Illinois
Recruiting
Clinical Study Site
Edwardsville
Illinois
Recruiting
Clinical Study Site
Indianapolis
Indiana
Recruiting
Clinical Study Site
Kansas City
Kansas
Recruiting
Clinical Study Site
Burlington
Massachusetts
Recruiting
Clinical Study Site
East Lansing
Michigan
Recruiting
Clinical Study Site
Omaha
Nebraska
Recruiting
Cinical Study Site
Lebanon
New Hampshire
Recruiting
Clinical Study Site
New York
New York
Recruiting
Clinical Study Site
New York
New York
Recruiting
Clinical Study Site
Cincinnati
Ohio
Recruiting
Clinical Study Site
Columbus
Ohio
Recruiting
Clinical Study Site
Portland
Oregon
Recruiting
Cinical Study Site
Nashville
Tennessee
Recruiting
Clinical Study Site
Dallas
Texas
Recruiting
Clinical Study Site
Denton
Texas
Recruiting
Cinical Study Site
Houston
Texas
Recruiting
Texas Locations
Houston
Texas
Recruiting
Clinical Study Site
Round Rock
Texas
Recruiting
Clinical Study Site
Sugar Land
Texas
Recruiting
Clinical Study Site
Seattle
Washington
Recruiting
Cinical Study Site
Buenos Aires
Buenos Aires
Recruiting
Cinical Study Site
Rosario
Santa Fe Province
Recruiting
Cinical Study Site #3
Buenos Aires
Argentina
Recruiting
Cinical Study Site #4
Buenos Aires
Argentina
Recruiting
Cinical Study Site
Buenos Aires
Argentina
Recruiting
Clinical Study Site #2
Buenos Aires
Argentina
Recruiting
Clinical Study Site
Buenos Aires
Argentina
Recruiting
Cinical Study Site #2
San Miguel de Tucumán
Argentina
Recruiting
+ 152 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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