Immunovant, Inc. (IMVT)
Immunovant, Inc. is a biopharmaceutical firm in the clinical development phase, dedicated to advancing novel monoclonal antibody therapies for the treatment of various autoimmune conditions. The company's primary focus is batoclimab, a pioneering, fully human monoclonal antibody. This antibody is engineered to specifically target and block the neonatal fragment crystallizable receptor (FcRn), a key mechanism in certain autoimmune diseases. Batoclimab is currently undergoing Phase IIa clinical evaluations for treating both myasthenia gravis and thyroid eye disease. Additionally, it has commenced Phase II clinical studies for patients suffering from warm autoimmune hemolytic anemia. Established in 2018, Immunovant operates from its headquarters in New York, New York, functioning as a subsidiary under the umbrella of Roivant Sciences Ltd.
Sector: Biological Products, (No Diagnostic Substances)
Industry: Biotechnology
Immunovant, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Terminated
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
Batoclimab 680 mg SC weekly, Batoclimab 340 mg SC weekly
Generalized Myasthenia Gravis
NCT05403541Enrollment233StartJun 2022Primary CompletionJan 2025CompletionAug 2026 - Phase 3Completed
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
Batoclimab, Placebo
Thyroid Eye Disease
NCT05517421Enrollment114StartNov 2022Primary CompletionNov 2025CompletionNov 2025 - Phase 3Terminated
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
Batoclimab
Thyroid Eye Disease
NCT05517447Enrollment109StartNov 2022Primary CompletionApr 2026CompletionApr 2026 - Phase 3Completed
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
Batoclimab, Placebo
Thyroid Eye Disease
NCT05524571Enrollment86StartJan 2023Primary CompletionFeb 2026CompletionMar 2026 - Phase 3Recruiting
Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
IMVT-1402, IMVT-1402
Generalized Myasthenia Gravis
NCT07039916Enrollment231StartMay 2025Primary CompletionDec 2027est.CompletionDec 2028est. - Phase 2Completed
A Study of RVT-1401 in Myasthenia Gravis (MG) Patients
RVT-1401, Placebo
Myasthenia Gravis
NCT03863080Enrollment17StartMay 2019Primary CompletionOct 2020CompletionDec 2020 - Phase 2Completed
Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy (GO)
RVT-1401
Graves' Ophthalmopathy
NCT03922321Enrollment7StartApr 2019Primary CompletionFeb 2020CompletionMay 2020 - Phase 2Terminated
ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )
RVT-1401 (Administered via subcutaneous injection)
Graves' Ophthalmopathy (GO)
NCT03938545Enrollment65StartJul 2019Primary CompletionFeb 2021CompletionApr 2021 - Phase 2Terminated
To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).
RVT-1401 680 mg/weekly, RVT-1401 340 mg/weekly
Warm Autoimmune Hemolytic Anemia
NCT04253236Enrollment5StartAug 2020Primary CompletionApr 2021CompletionApr 2021 - Phase 2Terminated
To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP
Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly, Batoclimab 340 mg SC weekly
Chronic Inflammatory Demyelinating Polyneuropathy
NCT05581199Enrollment94StartDec 2022Primary CompletionJul 2026CompletionJul 2026 - Phase 2Completed
A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease
IMVT-1401 (batoclimab)
Graves Disease
NCT05907668Enrollment32StartMay 2023Primary CompletionJul 2025CompletionJul 2025 - Phase 2Recruiting
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
IMVT-1402, IMVT-1402
Graves' Disease
NCT06727604Enrollment240StartDec 2024Primary CompletionJun 2028est.CompletionJun 2028est. - Phase 2Active, not recruiting
A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis
IMVT-1402, Placebo
Rheumatoid Arthritis
NCT06754462Enrollment120StartJan 2025Primary CompletionSep 2027est.CompletionSep 2027est. - Phase 2Active, not recruiting
Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
IMVT-1402, Placebo
Primary Sjögren's Syndrome
NCT06979531Enrollment180StartJun 2025Primary CompletionJul 2028est.CompletionJul 2029est. - Phase 2Active, not recruiting
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
IMVT-1402, Placebo
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
NCT06980805Enrollment56StartFeb 2025Primary CompletionOct 2026est.CompletionApr 2027est. - Phase 2Recruiting
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
IMVT-1402, IMVT-1402
Graves' Disease
NCT07018323Enrollment210StartJun 2025Primary CompletionMay 2027est.CompletionMay 2027est. - Phase 2Recruiting
Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Imeroprubart, Placebo
Chronic Inflammatory Demyelinating Polyneuropathy
NCT07032662Enrollment162StartMar 2025Primary CompletionAug 2028est.CompletionMay 2030est. - Phase 2Terminated
An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Batoclimab
Chronic Inflammatory Demyelinating Polyneuropathy
NCT07188844Enrollment26StartAug 2025Primary CompletionJul 2026CompletionJul 2026 - Phase 2Enrolling by invitation
A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD)
IMVT-1402
Graves' Disease
NCT07286006Enrollment372StartJan 2026Primary CompletionMar 2030est.CompletionMar 2030est.
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Terminated | Batoclimab 680 mg SC weekly, Batoclimab 340 mg SC weekly | NCT05403541 |
| Phase 3 | Completed | Batoclimab, Placebo | NCT05517421 |
| Phase 3 | Terminated | Batoclimab | NCT05517447 |
| Phase 3 | Completed | Batoclimab, Placebo | NCT05524571 |
| Phase 3 | Recruiting | IMVT-1402, IMVT-1402 | NCT07039916 |
| Phase 2 | Completed | RVT-1401, Placebo | NCT03863080 |
| Phase 2 | Completed | RVT-1401 | NCT03922321 |
| Phase 2 | Terminated | RVT-1401 (Administered via subcutaneous injection) | NCT03938545 |
| Phase 2 | Terminated | RVT-1401 680 mg/weekly, RVT-1401 340 mg/weekly | NCT04253236 |
| Phase 2 | Terminated | Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly, Batoclimab 340 mg SC weekly | NCT05581199 |
| Phase 2 | Completed | IMVT-1401 (batoclimab) | NCT05907668 |
| Phase 2 | Recruiting | IMVT-1402, IMVT-1402 | NCT06727604 |
| Phase 2 | Active, not recruiting | IMVT-1402, Placebo | NCT06754462 |
| Phase 2 | Active, not recruiting | IMVT-1402, Placebo | NCT06979531 |
| Phase 2 | Active, not recruiting | IMVT-1402, Placebo | NCT06980805 |
| Phase 2 | Recruiting | IMVT-1402, IMVT-1402 | NCT07018323 |
| Phase 2 | Recruiting | Imeroprubart, Placebo | NCT07032662 |
| Phase 2 | Terminated | Batoclimab | NCT07188844 |
| Phase 2 | Enrolling by invitation | IMVT-1402 | NCT07286006 |