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A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)
EU CTIS ID: 2024-517529-26-00
What this study is testing
To demonstrate the efficacy of DNTH103 compared to placebo based on the time to relapse.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Must have given written informed consent before any study-related activities are carried out.
- 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
- 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
You likely can't join if
- Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.
- 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.
- 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.
See the full eligibility criteria
Who can join
- Must have given written informed consent before any study-related activities are carried out.
- 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
- 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 fulfil one of the following treatment conditions for CIDP: a. 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. b.Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil. c. 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, due to side, experienced adverse effects, or have documented contraindications. d. 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
What rules you out
- Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Korea, Democratic People's Republic of
- Georgia
- United States
- Australia
- Malaysia
- United Kingdom
- Colombia
- North Macedonia
- Brazil
- Serbia
- Israel
- Japan
- China
- Argentina
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Korea, Democratic People's Republic of; Georgia; United States; Australia; Malaysia and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.