A Randomized, Double-Blind, Placebo Controlled, Phase 2b Study to Assess the Efficacy, Safety and Tolerability of IMVT-1402 as Treatment for Adult Patients with Graves’ Disease.
Protocol Number IMVT-1402-2502; Sponsor: Immunovant Sciences GmbH
Immunovant is a biotech company that is currently running multiple global trials. They have found that lowering IgG immune response has led to the reduction of pathogenic IgG antibodies in multiple autoimmune diseases including Myasthenia Gravis, CIDP, Thyroid Eye Disease (TED), and Graves’. Focusing on Graves’ treatment, this trial’s study medication is a once weekly subcutaneous injection with monoclonal antibody (IMVT-1402) that has also shown IgG reduction in healthy volunteers and may lead to a reduction in pathogenic TSHR-autoantibodies associated with both Graves’ and TED.
Summary of Study Details:
The study contains a Screening Period of up to 5 weeks to determine eligibility and 3 Treatment Periods. In the first 52 weeks, Periods 1 & 2, (26 weeks each) there are 21 visits and 2 phone calls. Study visits are more frequent for the first 2-3 months and move to once per month for the remainder of the year. You will enter the observation Period 3 If you are euthyroid and off antithyroid drugs (ATDs like methimazole), where you will discontinue study treatment up to 52 weeks. During the observation year you have study visits every 2 months to monitor your thyroid and other labs. If you move out of remission and require ATD treatment, your participation will end, and you will resume your regular treatment.
During the first 26 weeks, participants will be randomly assigned to one of three treatment arms. The first group will receive 600mg (2 consecutive injections of 300mg) each week for 52 weeks, the second treatment arm will receive the 600mg injection (same 2 injections of 300mg) for 26 weeks and depending on thyroid and antibody lab results may continue the 600mg treatment or move to blinded placebo for the remainder of the year. And the third group will receive placebo.
General Eligibility Criteria:
Graves’ diagnosis documented by either a positive thyroid scan consistent with Graves’ or a positive thyrotropin receptor antibody (TRAb) and or thyroid-stimulating immunoglobulin (TSI)
TSH < 0.1mIU/L
TRAb ≥ 3x upper limit of normal
One of the following:
Antithyroid drug (ATD) ≥ 3 months prior to Screening with a dose of ≥ 20mg/d methimazole or equivalent for 4 wk prior to Screening and anticipated to be on a stable dose for 4 wks prior to Randomization.
OR
ATD treatment for ≥ 6 months prior to Screening with a dose of ≥ 15mg/d methimazole or equivalent at any point during the participant’s treatment history, ≥ 10mg/d methimazole or equivalent for 4 wks prior to Screening and anticipated to be on a stable dose for 4 wks prior to Randomization.
Total IgG < 7 g/L
Liver function tests >2.5x upper limit of normal
Chronic kidney disease (eGRF < 45 mL/min/1.73 m2)
LDL >130 mg/dL
Albumin <3.5 g/dL
Recent serious infection or positive serology for HIV, HBV, HCV, TB
Must NOT have received non-live vaccine within 2 weeks or any live vaccine within 4 wks of Randomization
Must NOT have received immunoglobulin, plasma exchange, immunosuppressive action, Rituximab or complement inhibitors within 6/9 months of Screening
Must NOT have received any non-immunosuppressive Fc-based protein within 4 wks of Screening
Must NOT have used any oral or IV steroid within 12 wks of Screening
Must NOT have used T3 treatment within 6 weeks of Screening
Compensation: You will be paid $75 for each visit you complete and $25 for each phone visit, paid at the end of each visit. If you do not complete the study, you will be paid for all completed visits.
If interested in learning more, please contact our Research Coordinator, Jamie Sigg, RD, CDCES, CRC at 303-321-2644 x 214