ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )

Immunovant

Status and phase: Terminated; Phase 2

Conditions: Graves' Ophthalmopathy (GO)

Treatments: Other: Placebo (Administered via subcutaneous injection); Drug: RVT-1401 (Administered via subcutaneous injection)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03938545

RVT-1401-2001

Details and patient eligibility

About

The purpose of the current study is to assess the efficacy and safety/tolerability of three dose regimens of RVT-1401 in the treatment of active, moderate to severe GO participants. In addition, the study is designed to characterize the effect of RVT-1401 exposure on reduction in anti-TSHR IgG

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female ≥18 years of age.
2. Clinical diagnosis of Graves' disease with hyperthyroidism associated with active, moderate to severe Graves' Ophthalmopathy (GO) with a Clinical Activity Score (CAS) ≥4 for the most severely affected eye at Screening and Baseline (on the 7-item scale).
3. Onset of active GO within 9 months of screening.
4. Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction ≥2 millimeters (mm), moderate or severe soft tissue involvement, proptosis ≥3 mm above normal for race and gender, and/or inconstant or constant diplopia.
5. Other, more specific inclusion criteria are defined in the protocol

Exclusion criteria

1. Use of any steroid (intravenous, oral, steroid eye drops) for the treatment of GO or other conditions within 3 weeks prior to Screening. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids which are allowed.
2. Use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within the past 9 months prior to Baseline.
3. Total IgG level <6 grams per liter (g/L) at Screening.
4. Absolute neutrophil count <1500 cells per meter squared (cells/mm^3) at Screening.
5. Participants with decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months at Screening.
6. Previous orbital irradiation or surgery for GO.
7. Other, more specific exclusion criteria are defined in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 4 patient groups, including a placebo group

Regimen A-RVT-1401

Experimental group

Description:

Regimen A= RVT-1401 680 mg weekly for 12 weeks

Treatment:

Drug: RVT-1401 (Administered via subcutaneous injection)

Regimen B-RVT-1401

Experimental group

Description:

Regimen B= RVT-1401 340 mg weekly for 12 weeks

Treatment:

Drug: RVT-1401 (Administered via subcutaneous injection)

Regimen C-RVT-1401

Experimental group

Description:

Regimen C= RVT-1401 255 mg weekly for 12 weeks

Treatment:

Drug: RVT-1401 (Administered via subcutaneous injection)

Placebo

Placebo Comparator group

Description:

for 12 weeks

Treatment:

Other: Placebo (Administered via subcutaneous injection)