A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis

Study Purpose

This Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult participants with active, difficult-to-treat, anti-citrullinated protein autoantibody (ACPA) positive rheumatoid arthritis (RA).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male and Female participants of age >18 years will be enrolled.
  • - Diagnosis of 'definite RA' according to the 2010 ACR/ European Alliance of Associations for Rheumatology (EULAR) Rheumatoid Arthritis Classification Criteria.
  • - Greater than or equal to 6/68 in tender joint count (TJC) and ≥ 6/66 swollen joint count (SJC) at both Screening and Baseline visits.
  • - C-reactive protein ≥ upper limit of normal (ULN) at Screening Visit.
  • - Elevated immunoglobulin G (IgG) + ACPA at the Screening Visit.
  • - Inadequate response to at least 2 classes of biologic/targeted synthetic disease-modifying antirheumatic drugs (DMARDs).
Additional inclusion criteria are defined in the protocol.

Exclusion Criteria:

  • - 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.
  • - 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.
  • - Used any nonimmunosuppressive fragment crystallizable (Fc)-based therapeutic protein (e.g., monoclonal antibody [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, more specific exclusion criteria are defined in the protocol.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06754462
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Immunovant Sciences GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Bulgaria, Czechia, Georgia, Germany, Hungary, Poland, Romania, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Additional Details

The primary objective is to evaluate the effects of IMVT-1402 compared to placebo, as measured by the American College of Rheumatology 20% (ACR20) response at Week 28. The total duration of study participation is expected to be up to 86 weeks for an individual participant with 16 weeks of open-label treatment, 12 weeks of blinded randomized treatment, and 48 weeks of optional long-term extension treatment.

Arms & Interventions

Arms

Experimental: IMVT-1402 Dose 1

Experimental: IMVT-1402 Dose 2

Placebo Comparator: Placebo

Interventions

Drug: - IMVT-1402

Administered once weekly by subcutaneous injection.

Drug: - Placebo

Administered once weekly by subcutaneous injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Site Number - 1003, Anniston, Alabama

Status

Recruiting

Address

Site Number - 1003

Anniston, Alabama, 36207

Site Number - 1018, Mesa, Arizona

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Recruiting

Address

Site Number - 1018

Mesa, Arizona, 85210

Site Number - 1019, Sun City, Arizona

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Recruiting

Address

Site Number - 1019

Sun City, Arizona, 85351

Site Number - 1022, Covina, California

Status

Recruiting

Address

Site Number - 1022

Covina, California, 91722

Site Number - 1032, Fresno, California

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Not yet recruiting

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Site Number - 1032

Fresno, California, 93710

Site Number - 1028, San Leandro, California

Status

Recruiting

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Site Number - 1028

San Leandro, California, 94578

Site Number - 1024, Temecula, California

Status

Recruiting

Address

Site Number - 1024

Temecula, California, 92592

Site Number - 1033, Tujunga, California

Status

Recruiting

Address

Site Number - 1033

Tujunga, California, 91042

Site Number - 1023, Whittier, California

Status

Recruiting

Address

Site Number - 1023

Whittier, California, 90602

Site Number - 1020, Denver, Colorado

Status

Recruiting

Address

Site Number - 1020

Denver, Colorado, 80230

Site Number - 1015, Jupiter, Florida

Status

Recruiting

Address

Site Number - 1015

Jupiter, Florida, 33458

Site Number - 1002, Miami, Florida

Status

Recruiting

Address

Site Number - 1002

Miami, Florida, 33143

Site Number - 1027, Plantation, Florida

Status

Not yet recruiting

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Site Number - 1027

Plantation, Florida, 33324

Site Number - 1005, Winter Park, Florida

Status

Recruiting

Address

Site Number - 1005

Winter Park, Florida, 32789

Site Number - 1012, Zephyrhills, Florida

Status

Recruiting

Address

Site Number - 1012

Zephyrhills, Florida, 33542

Site Number - 1001, Gainesville, Georgia

Status

Recruiting

Address

Site Number - 1001

Gainesville, Georgia, 30501

Site Number - 1034, Chicago, Illinois

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Not yet recruiting

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Site Number - 1034

Chicago, Illinois, 60607

Site Number - 1006, Cumberland, Maryland

Status

Recruiting

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Site Number - 1006

Cumberland, Maryland, 21502

Site Number - 1007, Hagerstown, Maryland

Status

Recruiting

Address

Site Number - 1007

Hagerstown, Maryland, 21740

Site Number - 1008, Worcester, Massachusetts

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Not yet recruiting

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Site Number - 1008

Worcester, Massachusetts, 01655

Site Number - 1021, Saint Clair Shores, Michigan

Status

Recruiting

Address

Site Number - 1021

Saint Clair Shores, Michigan, 48081

Site Number - 1030, Kansas City, Missouri

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Not yet recruiting

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Site Number - 1030

Kansas City, Missouri, 64151

Site Number - 1010, Summit, New Jersey

Status

Recruiting

Address

Site Number - 1010

Summit, New Jersey, 07901

Site Number - 1004, Charlotte, North Carolina

Status

Recruiting

Address

Site Number - 1004

Charlotte, North Carolina, 28207

Site Number - 1000, Duncansville, Pennsylvania

Status

Recruiting

Address

Site Number - 1000

Duncansville, Pennsylvania, 16635

Site Number - 1016, Jackson, Tennessee

Status

Recruiting

Address

Site Number - 1016

Jackson, Tennessee, 38305

Site Number - 1026, Memphis, Tennessee

Status

Recruiting

Address

Site Number - 1026

Memphis, Tennessee, 38119

Site Number - 1029, Murfreesboro, Tennessee

Status

Recruiting

Address

Site Number - 1029

Murfreesboro, Tennessee, 37128

Site Number - 1017, Colleyville, Texas

Status

Recruiting

Address

Site Number - 1017

Colleyville, Texas, 76034

Site Number - 1014, Mesquite, Texas

Status

Recruiting

Address

Site Number - 1014

Mesquite, Texas, 75150

Site Number - 1013, Tomball, Texas

Status

Recruiting

Address

Site Number - 1013

Tomball, Texas, 77375

Site Number - 1025, Tomball, Texas

Status

Recruiting

Address

Site Number - 1025

Tomball, Texas, 77377

International Sites

Site Number - 5603, Plovdiv, Bulgaria

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Not yet recruiting

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Site Number - 5603

Plovdiv, , 4000

Site Number - 5605, Plovdiv, Bulgaria

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Not yet recruiting

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Site Number - 5605

Plovdiv, , 4002

Site Number - 5602, Plovdiv, Bulgaria

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Not yet recruiting

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Site Number - 5602

Plovdiv, , 4004

Site Number - 5604, Ruse, Bulgaria

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Not yet recruiting

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Site Number - 5604

Ruse, , 7000

Site Number - 5606, Sevlievo, Bulgaria

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Not yet recruiting

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Site Number - 5606

Sevlievo, , 5400

Site Number - 5600, Sofia, Bulgaria

Status

Not yet recruiting

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Site Number - 5600

Sofia, , 1336

Site Number - 5601, Sofia, Bulgaria

Status

Not yet recruiting

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Site Number - 5601

Sofia, , 1680

Site Number - 3204, Brno, Czechia

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Not yet recruiting

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Site Number - 3204

Brno, , 638 00

Site Number - 3202, Ostrava, Czechia

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Not yet recruiting

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Site Number - 3202

Ostrava, , 702 00

Site Number - 3203, Praha 2 Nové Město, Czechia

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Not yet recruiting

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Site Number - 3203

Praha 2 Nové Město, , 128 50

Site Number - 3201, Uherské Hradiště, Czechia

Status

Not yet recruiting

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Site Number - 3201

Uherské Hradiště, , 686 01

Site Number - 3200, Zlín, Czechia

Status

Not yet recruiting

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Site Number - 3200

Zlín, , 760 01

Site Number - 8002, Tbilisi, Georgia

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Not yet recruiting

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Site Number - 8002

Tbilisi, , 0102

Site Number - 8000, Tbilisi, Georgia

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Not yet recruiting

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Site Number - 8000

Tbilisi, , 0159

Site Number - 8001, Tbilisi, Georgia

Status

Not yet recruiting

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Site Number - 8001

Tbilisi, , 0160

Site Number - 8003, Tbilisi, Georgia

Status

Not yet recruiting

Address

Site Number - 8003

Tbilisi, , 0186

Site Number - 6500, Hamburg, Germany

Status

Not yet recruiting

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Site Number - 6500

Hamburg, , 20095

Site Number - 6501, Ratingen, Germany

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Not yet recruiting

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Site Number - 6501

Ratingen, , 40878

Site Number - 7554, Budapest, Hungary

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Not yet recruiting

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Site Number - 7554

Budapest, , 1027

Site Number - 7555, Budapest, Hungary

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Not yet recruiting

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Site Number - 7555

Budapest, , 1027

Site Number - 7550, Hódmezővásárhely, Hungary

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Not yet recruiting

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Site Number - 7550

Hódmezővásárhely, , 6800

Site Number - 7553, Kecskemét, Hungary

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Not yet recruiting

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Site Number - 7553

Kecskemét, , 6000

Site Number - 7551, Székesfehérvár, Hungary

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Not yet recruiting

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Site Number - 7551

Székesfehérvár, , 8000

Site Number - 7552, Veszprém, Hungary

Status

Not yet recruiting

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Site Number - 7552

Veszprém, , 8200

Site Number - 3001, Białystok, Poland

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Not yet recruiting

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Site Number - 3001

Białystok, , 15-077

Site Number - 3005, Białystok, Poland

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Not yet recruiting

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Site Number - 3005

Białystok, , 15-879

Site Number - 3007, Elbląg, Poland

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Not yet recruiting

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Site Number - 3007

Elbląg, , 82-300

Site Number - 3006, Nadarzyn, Poland

Status

Not yet recruiting

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Site Number - 3006

Nadarzyn, , 05-830

Site Number - 3008, Poznań, Poland

Status

Not yet recruiting

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Site Number - 3008

Poznań, , 60-848

Site Number - 3000, Poznań, Poland

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Not yet recruiting

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Site Number - 3000

Poznań, , 61-397

Site Number - 3003, Sochaczew, Poland

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Not yet recruiting

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Site Number - 3003

Sochaczew, , 96-500

Site Number - 3004, Warszawa, Poland

Status

Not yet recruiting

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Site Number - 3004

Warszawa, , 02-665

Site Number - 3002, Wrocław, Poland

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Not yet recruiting

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Site Number - 3002

Wrocław, , 53-673

Site Number - 7500, Braşov, Romania

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Not yet recruiting

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Site Number - 7500

Braşov, , 500283

Site Number - 7501, Râmnicu Vâlcea, Romania

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Not yet recruiting

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Site Number - 7501

Râmnicu Vâlcea, , 240636

Site Number - 7101, Bilbao, Spain

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Not yet recruiting

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Site Number - 7101

Bilbao, , 48013

Site Number - 7102, Málaga, Spain

Status

Not yet recruiting

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Site Number - 7102

Málaga, , 29009

Site Number - 7100, Sevilla, Spain

Status

Not yet recruiting

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Site Number - 7100

Sevilla, , 41009

Site Number - 7000, Edinburgh, United Kingdom

Status

Not yet recruiting

Address

Site Number - 7000

Edinburgh, , EH4 2XU

Site Number - 7001, London, United Kingdom

Status

Not yet recruiting

Address

Site Number - 7001

London, , SE5 9RJ

Site Number -7002, North Shields, United Kingdom

Status

Not yet recruiting

Address

Site Number -7002

North Shields, , NE29 8NH

Site Number - 7003, Wolverhampton, United Kingdom

Status

Not yet recruiting

Address

Site Number - 7003

Wolverhampton, , WV10 0QP