Clinical trial NCT06537999: A Clinical Study to Evaluate DNTH103 in Adults with Multifocal Motor Neuropathy
Official title: A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults with Multifocal Motor Neuropathy (MOMENTUM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multifocal Motor Neuropathy
Lead sponsor: Dianthus Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-08-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with multifocal motor neuropathy (MMN).


Eligibility criteria: Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are carried out
2. Adult males and females, 18 to 75 years of age (inclusive)
3. Weight range between 40 to 120 kg
4. Confirmed diagnosis of definite or probable MMN
5. Evidence of:

   1. Responsiveness to Ig treatment; and
   2. Receiving a stable Ig regimen
6. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability
7. 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
8. 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. History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or that could impact efficacy assessments
2. Any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy)
3. Concurrent or previous use of rituximab, cyclophosphamide, mycophenolate mofetil, azathioprine, or cyclosporine. If a participant has previously used these medications, the last dose must be at least 6 months prior to randomization
4. Currently or previously on complement inhibitors including in a clinical trial setting
5. Prior history (at any time) of N. meningitidis infection
6. Diagnosis of an autoimmune disorder other than MMN
7. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies during Screening
8. 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
9. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent (whichever is longer) prior to randomization (Day 1)
10. Any other overlapping condition for which the condition or treatment of the condition may affect the study assessments or outcomes
11. Any other condition, including mental illness or prior therapy, that in the opinion of the Investigator would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
timeFrame: Baseline to Week 17
Secondary outcomes:
measure: Time to first retreatment with immunoglobulin (Ig) since the final Ig treatment before randomization
timeFrame: Baseline to Week 17
measure: Time to first clinical deterioration (CD)
timeFrame: Baseline to Week 17
measure: Time between first retreatment with Ig and second retreatment with Ig
timeFrame: Baseline to Week 17
measure: Mean value, mean change, and percentage change from baseline in grip strength
timeFrame: Baseline to Week 17
measure: Area under curve (AUC) of the change from baseline in grip strength
timeFrame: Baseline to Week 17
measure: AUC of the change from baseline in Medical Research Council (MRC)-10 sum score
timeFrame: Baseline to Week 17
measure: Mean value and mean change from baseline in MRC-10 sum score
timeFrame: Baseline to Week 17
measure: Mean value and mean change from baseline in MRC-14 sum score
timeFrame: Baseline to Week 17
measure: Mean value and mean change from baseline in Multifocal Motor Neuropathy Rasch-Built Overall Disability Scale (MMN-RODS) score
timeFrame: Baseline to Week 17
measure: Mean value and mean change from baseline in average time to complete the 9-Hole Peg Test (9-HPT)
timeFrame: Baseline to Week 17
measure: Mean change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability score
timeFrame: Baseline to Week 17
measure: Mean change from baseline in Euro-Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) scale
timeFrame: Baseline to Week 17
measure: Mean change from baseline in EQ-5D-5L visual analog scale (VAS)
timeFrame: Baseline to Week 17
measure: Count and proportion of participants with Patient Global Impression of Change (PGIC) score of improved or better
timeFrame: Baseline to Week 17
measure: Mean change from baseline in Fatigue Severity Scale (FSS) score
timeFrame: Baseline to Week 17
measure: Mean change from baseline in Health-Related Productivity Questionnaire (HRPQ) outcomes
timeFrame: Baseline to Week 17
measure: Effectiveness, side effects, convenience, and overall satisfaction scores as assessed by Treatment Satisfaction Questionnaire for Medications (TSQM)-14
timeFrame: Baseline to Week 17
measure: Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
timeFrame: Up to Week 52 of OLE
measure: Serum concentrations of DNTH103
timeFrame: Baseline to Week 17
measure: Incidence and titer of antidrug antibody (ADA) levels against DNTH103
timeFrame: Baseline to Week 17
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clinical Study Site
state: Arizona
city: Bradenton
country: United States
facility: Clinical Study Site
state: Florida
city: Cincinnati
country: United States
facility: Clinical Study Site
state: Ohio
city: Columbus
country: United States
facility: Clinical Study Site
state: Ohio
city: Houston
country: United States
facility: Clinical Study Site
state: Texas
city: Aarhus
country: Denmark
facility: Clinical Study Site
city: Bydgoszcz
country: Poland
facility: Clinical Study Site
city: Katowice
country: Poland
facility: Clinical Study Site
Study officials:
References: