A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD)

Immunovant

Status and phase: Not yet enrolling; Phase 2

Conditions: Graves' Disease

Treatments: Drug: IMVT-1402

Study type: Interventional

Funder types: Industry

Identifiers

NCT07286006

IMVT-1402-2505

Details and patient eligibility

About

This is a long-term extension study that will rollover participants completing feeder studies IMVT-1402-2502 (NCT06727604) or IMVT-1402-2503 (NCT07018323) to evaluate the efficacy and safety of IMVT-1402 in adult participants with GD. Eligible participants will be assigned to 1 of 3 study groups (Groups A, B and C) based on their GD status at the completion of their respective feeder study.

Enrollment: 372 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who completed Study IMVT-1402-2502 or Study IMVT-1402-2503.
• Other, more specific inclusion criteria are defined in the protocol.

Exclusion criteria

• Have permanently discontinued IMP during the treatment period in the feeder study or have met study stopping criteria at any point up until the end of participation in the feeder study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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372 participants in 3 patient groups

Group A

Experimental group

Treatment:

Drug: IMVT-1402

Group B

No Intervention group

Group C

No Intervention group