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

Launched by DIANTHUS THERAPEUTICS · Feb 27, 2025

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ClinConnect Summary

This clinical trial, called CAPTIVATE, is studying a new treatment called DNTH103 for adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition that affects the nerves and can cause weakness and numbness. The trial aims to find out if DNTH103 is more effective than a placebo (a treatment that looks like the real drug but has no active ingredients) in helping people with this condition. Currently, the study is recruiting participants aged 18 to 80 who have been diagnosed with CIDP and are experiencing certain levels of disease activity.

To be eligible for the trial, participants must meet specific criteria, such as having a confirmed diagnosis of CIDP and being neurologically stable without any recent relapses. They should also be within a weight range of 40 to 120 kg and have been treated previously with certain medications for CIDP. Participants can expect to be monitored closely throughout the study, and they will need to provide written consent before starting. This trial is an important step in understanding how effective DNTH103 can be in treating CIDP and improving the quality of life for those affected.

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Eligibility criteria

• 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 (ie, no relapses or other neurological events that could affect examinations).
• • 6. Must have an adjusted 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 either no longer have access to or are no longer being treated with, 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, or previously treated with and responded to, but no longer have access to, oral corticosteroids.
• • 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 other causes, such as inflammatory neuropathies.
• • 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. Diagnosis of an autoimmune disorder other than CIDP.
• • 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.