Immunovant Sciences GmbH — Biomedical Watch V2

Traitements7programmes

Essais3liés

Publications0liées

SourceDBlocale

Traitements

7

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Batoclimab 340 mg SC bi-weeklyThe purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. The primary efficacy endpoint will be assessed by change in the myasthenia gravis activities of daily living (MG- ADL) score in acetylcholine receptor antibody seropositive (AChRAb+) participants. In Period 2, participants previously treated with batoclimab will be re-randomized to stay on batoclimab (340 mg SC QW or 340 mg SC every two weeks) or receive placebo treatment. The secondary endpoint of maintenance of efficacy will be assessed by change in the MG- ADL score in AChRAb+ participants. Participants demonstrating a response to batoclimab during either Period 1 or 2 may enter the long-term extension (Period 3). Participants who complete Period 3 are eligible to participate in Period 4 (Optional Long-Term extension) according to their treatment assignment in Period 3.	Myasthénie	Phase 3	À vérifier	United States, Argentina, Brazil, Canada, Georgia, Germany, Hungary, Italy, …	À vérifier
Batoclimab 340 mg SC weeklyThe purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. The primary efficacy endpoint will be assessed by change in the myasthenia gravis activities of daily living (MG- ADL) score in acetylcholine receptor antibody seropositive (AChRAb+) participants. In Period 2, participants previously treated with batoclimab will be re-randomized to stay on batoclimab (340 mg SC QW or 340 mg SC every two weeks) or receive placebo treatment. The secondary endpoint of maintenance of efficacy will be assessed by change in the MG- ADL score in AChRAb+ participants. Participants demonstrating a response to batoclimab during either Period 1 or 2 may enter the long-term extension (Period 3). Participants who complete Period 3 are eligible to participate in Period 4 (Optional Long-Term extension) according to their treatment assignment in Period 3.	Myasthénie	Phase 3	À vérifier	United States, Argentina, Brazil, Canada, Georgia, Germany, Hungary, Italy, …	À vérifier
Batoclimab 680 mg SC weeklyThe purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. The primary efficacy endpoint will be assessed by change in the myasthenia gravis activities of daily living (MG- ADL) score in acetylcholine receptor antibody seropositive (AChRAb+) participants. In Period 2, participants previously treated with batoclimab will be re-randomized to stay on batoclimab (340 mg SC QW or 340 mg SC every two weeks) or receive placebo treatment. The secondary endpoint of maintenance of efficacy will be assessed by change in the MG- ADL score in AChRAb+ participants. Participants demonstrating a response to batoclimab during either Period 1 or 2 may enter the long-term extension (Period 3). Participants who complete Period 3 are eligible to participate in Period 4 (Optional Long-Term extension) according to their treatment assignment in Period 3.	Myasthénie	Phase 3	À vérifier	United States, Argentina, Brazil, Canada, Georgia, Germany, Hungary, Italy, …	À vérifier
IMVT-1402The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.	Lupus, Myasthénie	Phase 2	À vérifier	United States, Argentina, Bulgaria, Canada, Chile, Georgia, Germany, Greece, …	À vérifier
IMVT-1402The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.	Myasthénie	Phase 3	À vérifier	United States, Argentina, Czechia, Denmark, Georgia, Germany, Greece, Hungary, Italy, Mexico, Poland, Romania, Serbia, Spain, United Kingdom	À vérifier
Batoclimab 680 mg SC weeklyThe purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. The primary efficacy endpoint will be assessed by change in the myasthenia gravis activities of daily living (MG- ADL) score in acetylcholine receptor antibody seropositive (AChRAb+) participants. In Period 2, participants previously treated with batoclimab will be re-randomized to stay on batoclimab (340 mg SC QW or 340 mg SC every two weeks) or receive placebo treatment. The secondary endpoint of maintenance of efficacy will be assessed by change in the MG- ADL score in AChRAb+ participants. Participants demonstrating a response to batoclimab during either Period 1 or 2 may enter the long-term extension (Period 3). Participants who complete Period 3 are eligible to participate in Period 4 (Optional Long-Term extension) according to their treatment assignment in Period 3.	Myasthénie	Phase 3	À vérifier	United States, Argentina, Brazil, Canada, Georgia, Germany, Hungary, Italy, Japan, Mexico, Poland, Romania, Serbia, South Korea, Spain, United Kingdom	À vérifier
IMVT-1402The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.	Lupus	Phase 2	À vérifier	United States, Argentina, Bulgaria, Canada, Chile, Georgia, Germany, Greece, Poland, Puerto Rico, Serbia, Spain, United Kingdom	À vérifier

Essais cliniques

3

Molécule	Indication / population	Phase	NCT	Titre	Statut
IMVT-1402	Lupus	Phase 2	NCT06980805	A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)	ACTIVE_NOT_RECRUITING
Batoclimab 680 mg SC weekly	Myasthénie	Phase 3	NCT05403541	Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis	TERMINATED
IMVT-1402	Myasthénie	Phase 3	NCT07039916	Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis	RECRUITING

Publications

0

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.