NCT06754462Active, not recruitingPhase 2
A Phase 2b to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With ACPA-Positive Rheumatoid Arthritis
A Phase 2b, Multicenter, Double-blind, Placebo-controlled Randomized Withdrawal Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult-to-Treat, ACPA-Positive Rheumatoid Arthritis
Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 Jul 2026
Brief summary (registry, in English)
To evaluate the effects of IMVT-1402 in participants with RA as assessed by American College of Rheumatology 20% (ACR20) Response
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 123 (estimated)
- First submitted
- 11 Feb 2025
- Start date
- 23 Jun 2025
- Lead sponsor
- Immunovant Sciences GmbH
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06754462
- EU CT number
- 2024-515973-82-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 123
- 36 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received rituximab and experienced insufficient efficacy or loss of efficacy.
- History of any chronic inflammatory arthritis with onset prior to age 18 or history of acute inflammatory joint disease of different origin from RA
- Used any nonimmunosuppresive Fc-based therapeutic protein (e.g., mAb or Fc-fusion protein) within 4 weeks prior to or at screening visit.
- 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
Other illness
- Active malignancy or history of malignancy within 5 years prior to screening visit
- Medical history of primary immunodeficiency, T cell or humoral, including common variable immunodeficiency.
Who the study is looking for
- Have a diagnosis of ‘definite RA’ according to the 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria
- Greater than or equal to 6/68 TJC and ≥ 6/66 SJC at both Screening and Baseline visits.
- C-reactive protein ≥ upper limit of normal (ULN) at screening visit
- Elevated immunoglobulin G (IgG) + ACPA as the Screening Visit.
- Inadequate response to at least 2 classes of biologic/targeted synthetic DMARDs
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Centre Epiona Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| Medical center "Artmed" LTD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd. Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| Medical Center Teodora EOOD Coordinator of this site? Confirm its status | Ruse | Bulgaria | Active, not recruiting |
| DCC 1 Sevlievo EOOD Coordinator of this site? Confirm its status | Sevlievo | Bulgaria | Active, not recruiting |
| Mbal Lyulin EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Diagnostics And Consultation Center Convex Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Revmatologie s.r.o. Coordinator of this site? Confirm its status | Brno-Sever | Czechia | Active, not recruiting |
| Vesalion s.r.o. Coordinator of this site? Confirm its status | Moravska Ostrava A Privoz | Czechia | Active, not recruiting |
| Revmatologicky Ustav Coordinator of this site? Confirm its status | Prague 2 | Czechia | Active, not recruiting |
| MEDICAL PLUS s.r.o. Coordinator of this site? Confirm its status | Uherské Hradiště | Czechia | Active, not recruiting |
| PV Medical Services s.r.o. Coordinator of this site? Confirm its status | Zlín | Czechia | Active, not recruiting |
| MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Studienambulanz Rheumazentrum Ratingen GbR Coordinator of this site? Confirm its status | Ratingen | Germany | Active, not recruiting |
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Completed |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Completed |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Budai Irgalmasrendi Korhaz Nonprofit Kft. Coordinator of this site? Confirm its status | Budapest | Hungary | Active, not recruiting |
| Revita Kft. Coordinator of this site? Confirm its status | Budapest II | Hungary | Active, not recruiting |
| Vasarhelyi Sarkanyfu Kft. Coordinator of this site? Confirm its status | Hódmezővásárhely | Hungary | Active, not recruiting |
| Je-Med Bt. Coordinator of this site? Confirm its status | Kalocsa | Hungary | Active, not recruiting |
| Complex Rendelo Med Zrt. Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Active, not recruiting |
| Vital-Medicina Kft. Coordinator of this site? Confirm its status | Veszprem | Hungary | Active, not recruiting |
| Clinicmed Daniluk Nowak Sp. k. Coordinator of this site? Confirm its status | Bialystok | Poland | Active, not recruiting |
| Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Coordinator of this site? Confirm its status | Elblag | Poland | Active, not recruiting |
| Reumed Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| NZOZ Lecznica MAK MED S C Coordinator of this site? Confirm its status | Nadarzyn | Poland | Active, not recruiting |
| Clinical Research Center Sp z o o Medic R Sp k Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| RCMed Oddzial Sochaczew Coordinator of this site? Confirm its status | Sochaczew | Poland | Active, not recruiting |
| Klinika Reuma Park Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L. Coordinator of this site? Confirm its status | Brasov | Romania | Active, not recruiting |
| Spitalul Clinic Dr. I. Cantacuzino Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Medaudio Optica S R L Coordinator of this site? Confirm its status | Râmnicu Vâlcea | Romania | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.