A Phase 2 Study to Evaluate DNTH103 in Adults with Multifocal Motor Neuropathy (MOMENTUM)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dianthus Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

6 Feb 2025 → ongoing

Decision date (initial)

2024-12-17

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Dianthus Therapeutics Inc.

External identifiers

EU CT number

2024-513128-40-00

ClinicalTrials.gov

NCT06537999

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Others, Efficacy, Pharmacodynamic, Safety

To evaluate the safety and tolerability of DNTH103 in participants with MMN up to Week 17

Secondary objectives 5

1. To evaluate the clinical efficacy of DNTH103 on muscle strength and functionality in participants with MMN compared to placebo up to Week 17
2. To evaluate the efficacy of DNTH103 on health-related quality of life, fatigue, and treatment satisfaction in participants with MMN compared to placebo up to Week 17.
3. To evaluate the safety and tolerability of DNTH103 in participants with MMN over 52 weeks of treatment in the OLE
4. To evaluate the PK and PD of DNTH103 in participants with MMN
5. To evaluate the immunogenicity of DNTH103

Conditions and MedDRA coding

Multifocal Motor Neuropathy

Study design 5 periods

Regulatory references

Scientific advice from competent authorities

Medicines Evaluation Board, Food And Drug Administration, Paul-Ehrlich-Institut

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

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: a. Responsiveness to Ig treatment; and b. 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 11

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)

Secondary endpoints 19

1. Time to retreatment with immunoglobulin (Ig) since the final Ig treatment before randomization
2. Time to clinical deterioration (CD)
3. Mean value, mean change, and percentage change from baseline in grip strength
4. Area under curve (AUC) of the change from baseline in grip strength
5. AUC of the change from baseline in Medical Research Council (MRC)-10 sum score
6. Mean value and mean change from baseline in MRC-10 sum score
7. Mean value and mean change from baseline in MRC-14 sum score
8. Mean value and mean change from baseline in Multifocal Motor Neuropathy Rasch-Built Overall Disability Scale (MMN-RODS) score
9. Mean value and mean change from baseline in average time to complete the 9-Hole Peg Test (9-HPT)
10. Mean change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability score
11. Mean change from baseline in Euro-Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) scale
12. Mean change from baseline in EQ-5D-5L visual analog scale (VAS)
13. Count and proportion of participants with Patient Global Impression of Change (PGIC) score of improved or better
14. Mean change from baseline in Fatigue Severity Scale (FSS) score
15. Mean change from baseline in Health-Related Productivity Questionnaire (HRPQ) outcomes
16. Effectiveness, side effects, convenience, and overall satisfaction scores as assessed by Treatment Satisfaction Questionnaire for Medications (TSQM)-14
17. Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
18. Serum concentrations of DNTH103
19. Incidence and titer of antidrug antibody (ADA) levels against DNTH103

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dianthus Therapeutics Inc.

Sponsor organisation

Dianthus Therapeutics Inc.

Address

7 Times Square Floor 43rd Suite 4303

City

New York

Postcode

10036-6508

Country

United States

Scientific contact point

Organisation

Dianthus Therapeutics Inc.

Contact name

Scientific CTIS contact point

Public contact point

Organisation

Dianthus Therapeutics Inc.

Contact name

Public CTIS contact point

Third parties 10

Locations

6 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 86 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications