Graves' disease is an immune system disorder that results in the overproduction of thyroid hormones.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Immunovant Sciences GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

14 Jun 2023 → 25 Jul 2025

Decision date (initial)

2024-09-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-512647-23-00

EudraCT number

2022-002894-27

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Pharmacodynamic, Safety, Therapy

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 objectives 2

1. 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 antithyroid drug (ATD) at Week 24
2. 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.

Conditions and MedDRA coding

Grave's disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Male or female ≥ 18 years of age.
2. Have 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 < lower limit of normal (LLN) • FT3 > upper limit of normal (ULN) and ≤ 5 x ULN • FT4 > ULN and ≤ 5 x ULN Note: Participants who have T3 thyrotoxicosis (i.e TSH < LLN, FT3 > 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 2 listed in this summary (numbered as Inclusion Criterion 1 in the Protocol).
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 ≥100 mg of propylthiouracil
5. Other, more specific inclusion criteria are defined in the protocol.

Exclusion criteria 7

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 or 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 inclusion criteria are defined in the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 2

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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Immunovant Sciences GmbH

Sponsor organisation

Immunovant Sciences GmbH

Address

Viaduktstrasse 8

City

Basel Town

Postcode

4051

Country

Switzerland

Scientific contact point

Organisation

Immunovant Sciences GmbH

Contact name

Immunovant Clinical Trials

Public contact point

Organisation

Immunovant Sciences GmbH

Contact name

Immunovant Clinical Trials

Third parties 5

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications