Clinical trial

An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis

Name

MOM-M281-005

Description

The purpose of this study is to evaluate the long-term safety and tolerability of M281 in participants with generalized myasthenia gravis (gMG)

Trial arms

Trial start

2019-08-06

Estimated PCD

2020-12-09

Trial end

2020-12-09

Status

Terminated

Phase

Early phase I

Treatment

M281

M281 injection administered as intravenous infusion

Arms:

M281

Size

Primary endpoint

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Up to 257 days post-baseline (Baseline is Day 1)

Number of Participants With Serious Adverse Events (SAEs)

Up to 257 days post-baseline

Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs)

Up to 257 days post-baseline

Number of Participants With Treatment-emergent Abnormal Vital Signs

Up to 257 days post-baseline

Number of Participants With Abnormalities in Physical Examinations

Week 12

Change From Baseline in Chemistry Laboratory Parameters: Albumin and Protein

Baseline up to Week 12

Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen

Baseline up to Week 12

Change From Baseline in Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase

Baseline up to Week 12

Change From Baseline in Chemistry Laboratory Parameters: Bilirubin, Creatinine and Direct Bilirubin

Baseline up to Week 12

Change From Baseline in Hematology Laboratory Parameter: Erythrocytes (Red Blood Cell)

Baseline up to Week 12

Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes

Baseline up to Week 12

Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration

Baseline up to Week 12

Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB)

Baseline up to Week 12

Change From Baseline in Hematology Laboratory Parameter: Erythrocytes Mean Corpuscular Volume

Baseline up to Week 12

Change From Baseline in Hematology Laboratory Parameter: Hematocrit

Baseline up to Week 12

Change From Baseline in Hematology Laboratory Parameter: Hemoglobin

Baseline up to Week 12

Change From Baseline in Urinalysis Laboratory Parameter: pH

Baseline up to Week 12

Change From Baseline in Urinalysis Laboratory Parameter: Specific Gravity

Baseline up to Week 12

Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values

Up to 257 days post-baseline

Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Scores

Up to 257 days post-baseline

Number of Participants With Below/Above Normal Values of Coagulation Laboratory Parameter

Up to 257 days post-baseline

Eligibility criteria

Participants must be ≥18 years of age with a documented history of Generalized Myasthenia Gravis (gMG) and clinical signs/symptoms of gMG, not pregnant or breastfeeding, previously participated in the MOM-281-004 study, had no major eligibility deviations or other major protocol deviations or not met any of the stopping criteria or discontinued study drug in the MOM-M281-004 study for any reason other than the need for rescue therapy as specified in the MOM-M281-004 study. Additional, more specific criteria are defined in the protocol.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}

Updated at

2023-06-27

1 organization

1 product

1 indication

Organization

Momenta Pharmaceuticals

Product

M281

Indication

Myasthenia Gravis