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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513128-40-00 | EU Trial (CTIS) Number |
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The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of Claseprubart (DNTH103) in participants with multifocal motor neuropathy (MMN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Claseprubart 300 mg Q2W | Experimental |
| |
| Claseprubart 600 mg Q2W | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Claseprubart | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs) | Baseline to Week 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Retreatment With Immunoglobulin (Ig) Since the Final Ig Treatment Before Randomization | Time between the participant's last dose of Ig and when they require the next dose of Ig after entering the randomized, controlled treatment period of the study | Baseline to Week 17 |
| Time to Clinical Deterioration (CD) |
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Inclusion Criteria:
Must have given written informed consent before any study-related activities are carried out
Adult males and females, 18 to 75 years of age (inclusive).
Weight range between 40 to 120 kilograms (kg).
Confirmed diagnosis of definite or probable MMN.
Evidence of:
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 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dianthus Clinical Contact Center | Contact | 929-999-4055 | clinicaltrials@dianthustx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Site | Recruiting | Scottsdale | Arizona | 85251 | United States | |
| Clinical Study Site |
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| Placebo | Drug |
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|
The time it takes a participant to meet defined criteria for worsening of symptoms in the study |
| Baseline to Week 17 |
| Mean Value, Mean Change, and Percentage Change From Baseline in Grip Strength | Grip strength measured in kilopascal (kPa) using a vigorimeter | Baseline to Week 17 |
| Area Under Curve (AUC) of the Change From Baseline in Grip Strength | Grip strength measured in kPa using a vigorimeter | Baseline to Week 17 |
| AUC of the Change From Baseline in Medical Research Council (MRC)-10 Sum Score | MRC-10 evaluates motor strength/weakness from a predetermined set of 10 muscle pairs (upper and lower limbs) on a scale of 0 to 5 | Baseline to Week 17 |
| Mean Value and Mean Change From Baseline in MRC-10 Sum Score | MRC-10 evaluates motor strength/weakness from a predetermined set of 10 muscle pairs (upper and lower limbs) on a scale of 0 to 5 | Baseline to Week 17 |
| Mean Value and Mean Change From Baseline in MRC-14 Sum Score | MRC-14 evaluates motor strength/weakness from a predetermined set of 14 muscle pairs (upper and lower limbs) on a scale of 0 to 5 | Baseline to Week 17 |
| Mean Value and Mean Change From Baseline in Multifocal Motor Neuropathy Rasch-Built Overall Disability Scale (MMN-RODS) Score | MMN-RODS consists of 25 items scored on a 3-point scale | Baseline to Week 17 |
| Mean Value and Mean Change From Baseline in Average Time to Complete the 9-Hole Peg Test (9-HPT) | 9-HPT is a quantitative measure of upper extremity (arm and hand) function and dexterity | Baseline to Week 17 |
| Mean Change From Baseline in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | INCAT comprises 2 parts, the arm score and the leg score. Each part is scored between 0 and 5 points, resulting in an INCAT total score between 0 and 10. Adjusted INCAT disability score excludes changes in upper limb function from 0 (normal) to 1 (minor symptoms) | Baseline to Week 17 |
| Mean Change From Baseline in Euro-Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) Scale | EQ-5D-5L is comprised of 5 dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression | Baseline to Week 17 |
| Mean Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) | A vertical VAS is included in the EQ 5D 5L. Participants mark their health status from 0 to 100 | Baseline to Week 17 |
| Count and Proportion of Participants With Patient Global Impression of Change (PGIC) Score of Improved or Better | PGIC is a 7-point scale depicting a participant's rating of overall improvement | Baseline to Week 17 |
| Mean Change From Baseline in Fatigue Severity Scale (FSS) Score | FSS assesses disabling fatigue in participants with chronic illness | Baseline to Week 17 |
| Mean Change From Baseline in Health-Related Productivity Questionnaire (HRPQ) Outcomes | HRPQ is a participant diary tool designed to provide data on health-related impacts to labor force participation | Baseline to Week 17 |
| Effectiveness, Side Effects, Convenience, and Overall Satisfaction Scores as Assessed by Treatment Satisfaction Questionnaire for Medications (TSQM)-14 | TSQM-14 is a 14-item treatment satisfaction questionnaire that evaluates the following domains: effectiveness, side effects, convenience, and global satisfaction | Baseline to Week 17 |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs) | Up to Week 52 of OLE |
| Serum Concentrations of Claseprubart | Blood samples will be collected for measurement of serum concentrations of Claseprubart at various timepoints both pre- and post-dose | Baseline to Week 17 |
| Incidence and Titer of Antidrug Antibody (ADA) Levels Against Claseprubart | Blood samples will be collected to measure ADA against Claseprubart at various timepoints | Baseline to Week 17 |
| Recruiting |
| Los Angeles |
| California |
| 90048 |
| United States |
| Clinical Study Site | Recruiting | Bradenton | Florida | 34205 | United States |
| Clinical Study Site | Recruiting | Tampa | Florida | 33620 | United States |
| Clinical Study Site | Recruiting | Honolulu | Hawaii | 96817 | United States |
| Clinical Study Site | Recruiting | Kansas City | Kansas | 66103 | United States |
| Clinical Study Site | Recruiting | Cincinnati | Ohio | 45219 | United States |
| Clinical Study Site | Recruiting | Columbus | Ohio | 43210 | United States |
| Clinical Study Site | Recruiting | Houston | Texas | 77030 | United States |
| Cinical Study Site | Recruiting | Toronto | Canada |
| Cinical Study Site | Recruiting | Beijing | 100053 | China |
| Clinical Study Site | Recruiting | Beijing | 100730 | China |
| Cinical Study Site | Recruiting | Shanghai | 200031 | China |
| Clinical Study Site | Recruiting | Aarhus | 8200 | Denmark |
| Clinical Study Site | Recruiting | Copenhagen | 1172 | Denmark |
| Clinical Study Site | Recruiting | Marseille | 13005 | France |
| Clinical Study Site | Recruiting | Paris | 94000 | France |
| Clinical Study Site | Recruiting | Rome | 00189 | Italy |
| Clinical Study Site | Recruiting | Kota Kinabalu | 88200 | Malaysia |
| Cinical Study Site | Recruiting | Kuala Lumpur | 50586 | Malaysia |
| Cinical Study Site | Recruiting | Kuala Lumpur | 59100 | Malaysia |
| Cinical Study Site | Recruiting | Permatang Pauh | 13700 | Malaysia |
| Cinical Study Site | Recruiting | Sarawak | 93586 | Malaysia |
| Clinical Study Site | Recruiting | Amsterdam | 1105 | Netherlands |
| Clinical Study Site | Recruiting | Utrecht | Netherlands |
| Clinical Study Site | Recruiting | Skopje | North Macedonia |
| Clinical Study Site | Recruiting | Bydgoszcz | 85-090 | Poland |
| Clinical Study Site | Recruiting | Katowice | 40-689 | Poland |
| Clinical Study Site | Recruiting | Krakow | 30-688 | Poland |
| Clinical Study Site | Recruiting | Krakow | 31-202 | Poland |
| Clinical Study Site | Recruiting | Belgrade | 11000 | Serbia |
| Cinical Study Site | Recruiting | Daegu | South Korea |
| Cinical Study Site #2 | Recruiting | Seoul | South Korea |
| Clinical Study Site | Recruiting | Seoul | South Korea |
| Cinical Study Site | Recruiting | Alicante | 03010 | Spain |
| Clinical Study Site | Recruiting | Barcelona | 08035 | Spain |
| Cinical Study Site | Recruiting | Barcelona | 08041 | Spain |
| Cinical Study Site | Recruiting | Istanbul | 34093 | Turkey (Türkiye) |
| Clinical Study Site | Recruiting | London | England | United Kingdom |
| Clinical Study Site | Recruiting | Oxford | England | United Kingdom |
| Clinical Study Site | Recruiting | Salford | England | United Kingdom |