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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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical Centre Epiona
Coordinator of this site? Confirm its status
PlovdivBulgariaActive, not recruiting
Medical center "Artmed" LTD
Coordinator of this site? Confirm its status
PlovdivBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.
Coordinator of this site? Confirm its status
PlovdivBulgariaActive, not recruiting
Medical Center Teodora EOOD
Coordinator of this site? Confirm its status
RuseBulgariaActive, not recruiting
DCC 1 Sevlievo EOOD
Coordinator of this site? Confirm its status
SevlievoBulgariaActive, not recruiting
Mbal Lyulin EAD
Coordinator of this site? Confirm its status
SofiyaBulgariaActive, not recruiting
Diagnostics And Consultation Center Convex Ltd.
Coordinator of this site? Confirm its status
SofiyaBulgariaActive, not recruiting
Revmatologie s.r.o.
Coordinator of this site? Confirm its status
Brno-SeverCzechiaActive, not recruiting
Vesalion s.r.o.
Coordinator of this site? Confirm its status
Moravska Ostrava A PrivozCzechiaActive, not recruiting
Revmatologicky Ustav
Coordinator of this site? Confirm its status
Prague 2CzechiaActive, not recruiting
MEDICAL PLUS s.r.o.
Coordinator of this site? Confirm its status
Uherské HradištěCzechiaActive, not recruiting
PV Medical Services s.r.o.
Coordinator of this site? Confirm its status
ZlínCzechiaActive, not recruiting
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Coordinator of this site? Confirm its status
HamburgGermanyActive, not recruiting
Studienambulanz Rheumazentrum Ratingen GbR
Coordinator of this site? Confirm its status
RatingenGermanyActive, not recruiting
Hospital Universitario Basurto
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BilbaoSpainCompleted
Hospital Universitario Regional de Málaga
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MálagaSpainCompleted
Parc Tauli Hospital Universitari
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SabadellSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Budai Irgalmasrendi Korhaz Nonprofit Kft.
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BudapestHungaryActive, not recruiting
Revita Kft.
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Budapest IIHungaryActive, not recruiting
Vasarhelyi Sarkanyfu Kft.
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HódmezővásárhelyHungaryActive, not recruiting
Je-Med Bt.
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KalocsaHungaryActive, not recruiting
Complex Rendelo Med Zrt.
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SzékesfehérvárHungaryActive, not recruiting
Vital-Medicina Kft.
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VeszpremHungaryActive, not recruiting
Clinicmed Daniluk Nowak Sp. k.
Coordinator of this site? Confirm its status
BialystokPolandActive, not recruiting
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
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ElblagPolandActive, not recruiting
Reumed Sp. z o.o.
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LublinPolandActive, not recruiting
NZOZ Lecznica MAK MED S C
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NadarzynPolandActive, not recruiting
Clinical Research Center Sp z o o Medic R Sp k
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PoznanPolandActive, not recruiting
Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj
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PoznanPolandActive, not recruiting
RCMed Oddzial Sochaczew
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SochaczewPolandActive, not recruiting
Klinika Reuma Park Sp. z o.o. S.K.
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WarsawPolandActive, not recruiting
Futuremeds Sp. z o.o.
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WroclawPolandActive, not recruiting
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Coordinator of this site? Confirm its status
BrasovRomaniaActive, not recruiting
Spitalul Clinic Dr. I. Cantacuzino
Coordinator of this site? Confirm its status
BucharestRomaniaActive, not recruiting
Medaudio Optica S R L
Coordinator of this site? Confirm its status
Râmnicu VâlceaRomaniaActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.