What is the Purpose of this Study?
The purpose of this study is to evaluate safety and effectiveness of an experimental drug called DNTH103 for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) when compared to a placebo (inactive substance). Participants are those who have or possibly have CIDP, a condition in which the body’s immune system mistakenly attacks and damages the protective covering of nerves (called myelin) throughout the body. This damage disrupts the normal communication between the nerves and muscles, leading to weakness, numbness, pain, and tingling sensations. The most common form of CIDP typically affects both sides of the body, particularly the lower limbs (e.g. legs) and upper limbs (e.g. hands & wrists), leading to movement and balance problems. Study procedures include administration of the experimental medication or placebo, questionnaires, evaluations, electrocardiograms, and blood samples.
Participants will receive DNTH103 in the first part of the study (Part A). If the patient’s CIDP improves, they may qualify for the second part of the study (Part B), during which they will receive DNTH103 or placebo. Researchers believe that DNTH103 may decrease or prevent the injury (caused by CIDP) to the nerves that control the muscles.
Eligibility
- 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.
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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 failure (worsened) or an inadequate response (defined as no clinically meaningful improvement after treatment for a minimum of 12 weeks on Ig and/or oral corticosteroids) or are unable to tolerate these treatments due to side effects.
- 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 be surgically sterile for at least 90 days prior to Screening or 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.
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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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DNTH103 IN ADULTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY