A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)
PHASE3RECRUITING
The purpose of this Phase 3 study is to demonstrate the efficacy of DNTH103 as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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: 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. Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil. 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. 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 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
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06858579
Intervention or treatment
DRUG: DNTH103
DRUG: DNTH103
DRUG: Placebo
Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy
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Research sites nearby
Closest Location:
Clinical Study Site
Select from list below to view details:
Clinical Study Site
Randwick, New South Wales, Australia
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Who is running the clinical trial?
DT
Dianthus Therapeutics
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?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Claseprubart (Part A)
| Drug: Claseprubart |
EXPERIMENTAL: Claseprubart (Part B)
| Drug: Claseprubart |
PLACEBO_COMPARATOR: Placebo (Part B)
| Drug: Placebo |
EXPERIMENTAL: Claseprubart (Optional OLE)
| Drug: Claseprubart |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Time From First Dose to Relapse as Assessed by the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) | 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
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Time to Decrease of ≥ 4 Points (Centile Metric) in Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score | 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 | This is measured with a handheld device called a vigorimeter. | Part B baseline to Part B end of treatment period (up to Week 52) |
| Part B: Percentage of Participants who Relapse as Assessed by the Adjusted INCAT | 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 I-RODS Score | 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) |
| Parts A and B: Change in Grip Strength in the Dominant Hand | 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 | 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 | 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) | 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 | 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) | 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) | 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 | 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 | 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) | 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 | 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) | 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) | 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) |
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References
Clinical Trials Gov: A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)Other trials to consider
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