A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis
NCT ID: NCT06754462
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-01-10
2027-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IMVT-1402 Dose 1
IMVT-1402
Administered once weekly by subcutaneous injection.
IMVT-1402 Dose 2
IMVT-1402
Administered once weekly by subcutaneous injection.
Placebo
Placebo
Administered once weekly by subcutaneous injection.
Interventions
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IMVT-1402
Administered once weekly by subcutaneous injection.
Placebo
Administered once weekly by subcutaneous injection.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Immunovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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Site Number - 1018
Mesa, Arizona, United States
Site Number - 1019
Sun City, Arizona, United States
Site Number - 1022
Covina, California, United States
Site Number - 1028
San Leandro, California, United States
Site Number - 1024
Temecula, California, United States
Site Number - 1033
Tujunga, California, United States
Site Number - 1023
Whittier, California, United States
Site Number - 1020
Denver, Colorado, United States
Site Number - 1015
Jupiter, Florida, United States
Site Number - 1002
Miami, Florida, United States
Site Number - 1027
Plantation, Florida, United States
Site Number - 1005
Winter Park, Florida, United States
Site Number - 1012
Zephyrhills, Florida, United States
Site Number - 1001
Gainesville, Georgia, United States
Site Number - 1034
Chicago, Illinois, United States
Site Number - 1006
Cumberland, Maryland, United States
Site Number - 1007
Hagerstown, Maryland, United States
Site Number - 1031
Rockville, Maryland, United States
Site Number - 1008
Worcester, Massachusetts, United States
Site Number - 1021
Saint Clair Shores, Michigan, United States
Site Number - 1030
Kansas City, Missouri, United States
Site Number - 1010
Summit, New Jersey, United States
Site Number - 1004
Charlotte, North Carolina, United States
Site Number - 1035
Statesville, North Carolina, United States
Site Number - 1000
Duncansville, Pennsylvania, United States
Site Number - 1016
Jackson, Tennessee, United States
Site Number - 1026
Memphis, Tennessee, United States
Site Number - 1029
Murfreesboro, Tennessee, United States
Site Number - 1037
Allen, Texas, United States
Site Number - 1017
Colleyville, Texas, United States
Site Number - 1036
Katy, Texas, United States
Site Number - 1014
Mesquite, Texas, United States
Site Number - 1013
Tomball, Texas, United States
Site Number - 1025
Tomball, Texas, United States
Site Number - 5003
Buenos Aires, , Argentina
Site Number - 5001
Buenos Aires, , Argentina
Site Number -5004
Buenos Aires, , Argentina
Site Number - 5002
Buenos Aires, , Argentina
Site Number - 5005
Buenos Aires, , Argentina
Site Number - 5000
San Miguel de Tucumán, , Argentina
Site Number - 5603
Plovdiv, , Bulgaria
Site Number - 5605
Plovdiv, , Bulgaria
Site Number - 5602
Plovdiv, , Bulgaria
Site Number - 5604
Rousse, , Bulgaria
Site Number - 5606
Sevlievo, , Bulgaria
Site Number - 5600
Sofia, , Bulgaria
Site Number - 5601
Sofia, , Bulgaria
Site Number - 3204
Brno, , Czechia
Site Number - 3202
Ostrava, , Czechia
Site Number - 3203
Praha 2 Nove Mesto, , Czechia
Site Number - 3201
Uherské Hradiště, , Czechia
Site Number - 3200
Zlín, , Czechia
Site Number - 8000
Tbilisi, , Georgia
Site Number - 8001
Tbilisi, , Georgia
Site Number - 8003
Tbilisi, , Georgia
Site Number - 6500
Hamburg, , Germany
Site Number - 6501
Ratingen, , Germany
Site Number - 7554
Budapest, , Hungary
Site Number - 7555
Budapest, , Hungary
Site Number - 7550
Hódmezővásárhely, , Hungary
Site Number - 7553
Kecskemét, , Hungary
Site Number - 7551
Székesfehérvár, , Hungary
Site Number - 7552
Veszprém, , Hungary
Site Number - 3005
Bialystok, , Poland
Site Number - 3007
Elblag, , Poland
Site Number - 3009
Lublin, , Poland
Site Number - 3006
Nadarzyn, , Poland
Site Number - 3008
Poznan, , Poland
Site Number - 3000
Poznan, , Poland
Site Number - 3003
Sochaczew, , Poland
Site Number - 3004
Warsaw, , Poland
Site Number - 3002
Wroclaw, , Poland
Site Number - 7500
Brasov, , Romania
Site Number - 7501
Râmnicu Vâlcea, , Romania
Site Number - 7104
Barcelona, , Spain
Site Number - 7101
Bilbao, , Spain
Site Number - 7102
Málaga, , Spain
Site Number - 7100
Seville, , Spain
Site Number - 7000
Edinburgh, , United Kingdom
Site Number - 7001
London, , United Kingdom
Site Number -7002
North Shields, , United Kingdom
Site Number - 7003
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-515973-82-00
Identifier Type: CTIS
Identifier Source: secondary_id
IMVT-1402-2601
Identifier Type: -
Identifier Source: org_study_id