Graves` disease MedDRA version: 26.0 Level: PT Classification code 10018706 Term: Graves' disease System Organ Class: 10014698 - Endocrine disorders
Conditions
Sponsors
Immunovant Sciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female >= 18 years of age. 2. Have a serologically confirmed GD as documented by presence of elevated stimulatory TSH-R-Ab level (i.e., > SRR 140 %) at the Screening Visit. 3. Have active hyperthyroidism due to GD with the following laboratory values at the Screening Visit: • TSH upper limit of normal (ULN) and =5× ULN • FT4 > ULN and =5 × ULN Note: Participants who have T3 thyrotoxicosis (i.e., TSH ULN and =5× ULN, but FT4 within normal range) at the Screening Visit may be enrolled, if they have serologically confirmed GD as per Inclusion Criterion 1. 4. Meet all of the following ATD requirements at the Screening Visit: • Have been on an ATD for =12 weeks before the Screening Visit. • Had starting total daily ATD dose of =20 mg of methimazole or carbimazole, or =200 mg of propylthiouracil. • Are currently treated with a total daily dose of =10 mg of methimazole or carbimazole, or =100 mg of propylthiouracil. 5. Other, more specific inclusion criteria are defined in the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and/or history or presence of thyroid storm. 2. History of treatment with radioactive iodine or thyroid surgery. Note: Participants may be enrolled if they meet Inclusion Criteria 3 and 4 listed in this summary (numbered as Inclusion Criteria 2 and 3 in the Protocol). 3. Total IgG level <6 grams per liter (g/L) at the Screening Visit. 4. Albumin level <3.5 grams per deciliter (g/dL) (<35 g/L) at the Screening Visit. 5. Absolute neutrophil count <1000 cells per cubic millimeter (cells/mm^3) at the Screening Visit. 6. Have been enrolled in a previous RVT-1401, IMVT-1401 clinical trial. Note: Participants previously enrolled in an IMVT-1401 clinical trial, with documented assignment to placebo treatment only, may be enrolled in this study. 7. Other, more specific exclusion criteria are defined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effects of batoclimab on thyroid hormone levels in participants with GD as assessed by reduction of FT3 and FT4 at Week 24;Secondary Objective: To investigate the effects of batoclimab on thyroid hormone levels in participants with GD as assessed by reduction of FT3 and FT4 and changes in ATD at Week 24. To investigate the effects of batoclimab on thyroid hormone levels in participants with GD as assessed by reduction of FT3 and FT4 at Week 24 and ATD treatment. ;Primary end point(s): Proportion of participants who, at Week 24, without increase in ATD dose compared to baseline, have achieved normalization of FT3 and FT4, or have FT3 and/or FT4 below the LLN.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of participants who achieve normalization of FT3 and FT4 at Week 24 with ATD dose =50% of the baseline ATD dose by Week 24. 2. Proportion of participants who are off ATD treatment and achieve normalization of FT3 and FT4, or have FT3 and/or FT4 below the LLN at Week 24. ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Germany
Contacts
Public ContactCentral Study Contact
Immunovant Sciences GmbH
Outcome results
None listed