A Phase 2b to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With ACPA-Positive Rheumatoid Arthritis

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

23 Jun 2025 → ongoing

Decision date (initial)

2025-06-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515973-82-00

ClinicalTrials.gov

NCT06754462

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Pharmacokinetic, Efficacy, Safety, Pharmacodynamic

To evaluate the effects of IMVT-1402 in participants with RA as assessed by American College of Rheumatology 20% (ACR20) Response

Conditions and MedDRA coding

ACPA-Positive Rheumatoid Arthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Have a diagnosis of ‘definite RA’ according to the 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria
2. Greater than or equal to 6/68 TJC and ≥ 6/66 SJC at both Screening and Baseline visits.
3. C-reactive protein ≥ upper limit of normal (ULN) at screening visit
4. Elevated immunoglobulin G (IgG) + ACPA as the Screening Visit.
5. Inadequate response to at least 2 classes of biologic/targeted synthetic DMARDs

Exclusion criteria 6

1. Have received rituximab and experienced insufficient efficacy or loss of efficacy.
2. History of any chronic inflammatory arthritis with onset prior to age 18 or history of acute inflammatory joint disease of different origin from RA
3. Active malignancy or history of malignancy within 5 years prior to screening visit
4. Medical history of primary immunodeficiency, T cell or humoral, including common variable immunodeficiency.
5. Used any nonimmunosuppresive Fc-based therapeutic protein (e.g., mAb or Fc-fusion protein) within 4 weeks prior to or at screening visit.
6. Used any anti-FcRn treatment within 2 months prior to or at Screening Visit or have a documented history of non-response to prior anti-FcRn treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants who achieve ACR20 response at Week 28.

Secondary endpoints 2

1. Change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28.
2. Change in Simplified Disease Activity Index (SDAI) score from week 16 to Week 28

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 10

Locations

7 EU/EEA countries · 37 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 208 files

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

Application history

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