A Phase 2b Study to Assess the Efficacy and Safety of IMVT-1402 in Patients with Grave’s Disease

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

26 Jun 2025 → ongoing

Decision date (initial)

2025-06-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-516020-33-00

ClinicalTrials.gov

NCT06727604

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Pharmacodynamic, Efficacy, Therapy

To evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (Total T3 or FT3), FT4, TSH, and ATD at Week 26

Conditions and MedDRA coding

Grave’s Disease

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Are ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form (ICF)
2. Have a prior diagnosis of GD documented
3. Have TSH assessed by the local laboratory below the following thresholds at the Screening Visit
4. Meet both of the following at the Screening Visit: a. Have been on ATD for ≥ 3 months in the period immediately preceding the Screening Visit and the following: i. Are on ATD at the Screening Visit with an ATD dose ≥ 20 mg/day methimazole or equivalent (i.e., ≥ 30 mg/day carbimazole, ≥ 200 mg/day propylthiouracil) for the 4-week period immediately preceding the Screening Visit. ii. Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization. b. Have been on ATD for ≥ 6 months in the period immediately preceding the Screening Visit and both of the following: i. Have been treated with ≥ 15 mg/day methimazole or equivalent (i.e., ≥ 20 mg/day carbimazole, ≥ 150 mg/day propylthiouracil) at any point during the participant's treatment history. ii. Are on ATD at the Screening Visit with an ATD dose ≥ 10 mg/day methimazole or equivalent (i.e., ≥ 15 mg/day carbimazole, ≥ 100 mg/day propylthiouracil) for the 4-week period immediately preceding the Screening Visit. iii. Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.

Exclusion criteria 6

1. Have previously been successfully treated with RAI therapy or have undergone total thyroidectomy.
2. Have a T3 (Total T3 or FT3, as available and per standard of care at local laboratory) or FT4 value < LLN as assessed by the local laboratory at the Screening Visit
3. Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks of the Screening Visit. Note: Participants receiving block-and-replace treatment are not eligible.
4. Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within 6 months of the Screening Visit
5. Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.
6. Have moderate-to-severe active TED and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants who are euthyroid and off ATD at Week 26

Secondary endpoints 11

1. Proportion of participants who are euthyroid and off ATD at Week 52
2. Proportion of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52
3. Proportion of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 52 to Week 78
4. Proportion of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 52 to Week 104
5. Proportion of participants who have a TRAb value at Week 25 and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52
6. Proportion of participants who have a TRAb value at Week 25 and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 26 to Week 78
7. Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline
8. Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline
9. Proportion of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26
10. Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26
11. Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 52

Investigational products

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

Test 1

Placebo 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 17

Locations

6 EU/EEA countries · 46 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 190 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