A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy

Официальное название

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)

Обзор

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).

Вмешательства

• Препарат Claseprubart
  * Day 1: IV loading dose * Week 1 to Week 15: Claseprubart administered SC every 2 weeks
• Препарат Placebo
  * Day 1: IV infusion of placebo * Week 1 to Week 15: placebo administered SC every 2 weeks

Первичные конечные точки

• Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) [Срок оценки: Baseline to Week 17]

Вторичные конечные точки (12)

• Time to Retreatment With Immunoglobulin (Ig) Since the Final Ig Treatment Before Randomization [Срок оценки: Baseline to Week 17]
• Time to Clinical Deterioration (CD) [Срок оценки: Baseline to Week 17]
• Mean Value, Mean Change, and Percentage Change From Baseline in Grip Strength [Срок оценки: Baseline to Week 17]
• Area Under Curve (AUC) of the Change From Baseline in Grip Strength [Срок оценки: Baseline to Week 17]
• AUC of the Change From Baseline in Medical Research Council (MRC)-10 Sum Score [Срок оценки: Baseline to Week 17]
• Mean Value and Mean Change From Baseline in MRC-10 Sum Score [Срок оценки: Baseline to Week 17]
• Mean Value and Mean Change From Baseline in MRC-14 Sum Score [Срок оценки: Baseline to Week 17]
• Mean Value and Mean Change From Baseline in Multifocal Motor Neuropathy Rasch-Built Overall Disability Scale (MMN-RODS) Score [Срок оценки: Baseline to Week 17]
• Mean Value and Mean Change From Baseline in Average Time to Complete the 9-Hole Peg Test (9-HPT) [Срок оценки: Baseline to Week 17]
• Mean Change From Baseline in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score [Срок оценки: Baseline to Week 17]
• Mean Change From Baseline in Euro-Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) Scale [Срок оценки: Baseline to Week 17]
• Mean Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) [Срок оценки: Baseline to Week 17]

Критерии участия

Критерии включения

• 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:

• Responsiveness to Ig treatment; and
• Receiving a stable Ig regimen
• 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.

Критерии исключения

• 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.
• Any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy).
• 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.
• Currently or previously on complement inhibitors including in a clinical trial setting.
• Prior history (at any time) of N. meningitidis infection.
• Diagnosis of an autoimmune disorder other than MMN.
• 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.
• 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.
• 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).
• Any other overlapping condition for which the condition or treatment of the condition may affect the study assessments or outcomes.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 9 центров

• Clinical Study Site — Scottsdale
• Clinical Study Site — Los Angeles
• Clinical Study Site — Bradenton
• Clinical Study Site — Tampa
• Clinical Study Site — Honolulu
• Clinical Study Site — Kansas City
• Clinical Study Site — Cincinnati
• Clinical Study Site — Columbus
• … и ещё 1 центр

Малайзия · 5 центров

• Clinical Study Site — Kota Kinabalu
• Cinical Study Site — Kuala Lumpur
• Cinical Study Site — Kuala Lumpur
• Cinical Study Site — Permatang Pauh
• Cinical Study Site — Sarawak

Польша · 4 центра

• Clinical Study Site — Bydgoszcz
• Clinical Study Site — Katowice
• Clinical Study Site — Krakow
• Clinical Study Site — Krakow

Китай · 3 центра

• Cinical Study Site — Пекин
• Clinical Study Site — Пекин
• Cinical Study Site — Шанхай

South Korea · 3 центра

• Cinical Study Site — Daegu
• Cinical Study Site #2 — Seoul
• Clinical Study Site — Seoul

Испания · 3 центра

• Cinical Study Site — Alicante
• Clinical Study Site — Barcelona
• Cinical Study Site — Barcelona

Великобритания · 3 центра

• Clinical Study Site — London
• Clinical Study Site — Oxford
• Clinical Study Site — Salford

Дания · 2 центра

• Clinical Study Site — Aarhus
• Clinical Study Site — Copenhagen

Франция · 2 центра

• Clinical Study Site — Marseille
• Clinical Study Site — Paris

Нидерланды · 2 центра

• Clinical Study Site — Amsterdam
• Clinical Study Site — Utrecht

Канада · 1 центр

• Cinical Study Site — Toronto

Италия · 1 центр

• Clinical Study Site — Rome

North Macedonia · 1 центр

• Clinical Study Site — Skopje

Сербия · 1 центр

• Clinical Study Site — Belgrade

Turkey (Türkiye) · 1 центр

• Cinical Study Site — Istanbul

Идентификаторы

NCT: NCT06537999 · DNTH103-MMN-201 · 2024-513128-40-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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