Neoplasms

Nervous System Diseases

Immune System Diseases

All Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Rare Diseases

Myasthenia Gravis

Asthenia

Muscle Weakness

Paresis

Muscular Diseases

Neuromuscular Manifestations

Neurologic Manifestations

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neurodegenerative Diseases

Neuromuscular Junction Diseases

Neuromuscular Diseases

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Autoantibodies

Immunoglobulins

Rozanolixizumab

Immunosuppressive Agents

Immunologic Factors

Subjects randomized in dosage regimen 1 will receive 3 doses of UCB7655 (dose 1) in dosing period 1 and will then be re-randomized into dosing period 2 to receive 3 doses of UCB7665 (dose 1 or dose 2).

Subjects randomized in dosage regimen 2 will receive 3 doses of placebo in dosing period 1 and will then be re-randomized into dosing period 2 to receive 3 doses of UCB7665 (dose 1 or dose 2).

UCB7665 will be administered in 2 different dosages (dose 1 and dose 2). UCB7665 (INN: Rozanolixizumab) is a humanized monoclonal antibody that is being developed for treatment of IgG autoantibody-mediated conditions such as myasthenia gravis (MG)

UCB7665

Placebo will be administered in period 1 of dosage regimen 2.

Placebo

UCB Cares

The purpose of the study is to evaluate the clinical efficacy of UCB7665 as a chronic-intermittent treatment in subjects with generalized myasthenia gravis (MG) who are classified as moderate to severe.

This is an Investigator- and Subject-Blind study.

Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis

A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis

The total QMG score was obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

The total Myasthenia Gravis (MG)-composite score was obtained by summing the responses to each individual item (10 items; Grade: 0-9 depending on item). The score ranges from 0 to 50, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

The total MGDAL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3). The score ranges from 0 to 24, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

UCB Biopharma S.P.R.L.

Participants received 3 doses of placebo in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg). Participants formed the Safety Set (SS) which consisted of all participants in the Randomized Set (RS) who had received at least 1 dose of investigational product (IMP).

Placebo (SS)

Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg). Participants formed the Safety Set (SS) which consisted of all participants in the Randomized Set (RS) who had received at least 1 dose of investigational product (IMP).

UCB7665 (7 mg/kg) (SS)

Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).

Placebo - UCB7665 (7 mg/kg) (SS)

Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).

Placebo - UCB7665 (4 mg/kg) (SS)

Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).

UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg) (SS)

Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).

UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg) (SS)

Participants received 3 doses of placebo in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg).

Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg).

UCB7665 (7 mg/kg)

Total Title

Age, Categorical

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Baseline Characteristics refer to the Randomized Set (RS) which consisted of all participants randomized into the study at the first randomization visit.

Mixed Model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline QMG score, and random effect for participant.

The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'.

Participants received 3 doses of placebo in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).

Placebo (FAS)

Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).

UCB7665 (7 mg/kg) (FAS)

The FAS consisted of all participants in the SS who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).

Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score to Visit 9

MMRM ANCOVA model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline MG-composite score, and random effect for participant.

The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'.

Change From Baseline in Myasthenia Gravis-Composite Score to Visit 9

ANCOVA model included fixed terms for treatment group, covariate of Baseline MGADL score.

Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) Score to Visit 9

Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2.

Placebo - UCB7665 (7 mg/kg)

Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2.

Placebo - UCB7665 (4 mg/kg)

Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2.

UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg)

Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2.

Spots Global Cancer Trial Database for Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis

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