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

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Immunovant Sciences GmbH
Study ID
NCT06754462
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMVT-1402 — DRUG
    Administered once weekly by subcutaneous injection.
  • Placebo — DRUG
    Administered once weekly by subcutaneous injection.

Study Details

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).

Key Dates

Start date
Jan 10, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IMVT-1402 Dose 1
  • Experimental: IMVT-1402 Dose 2
  • Placebo Comparator: Placebo

Primary Outcome Measure

Proportion of participants who maintain ACR20 response at Week 28 [ Time Frame: Week 28 ]

Locations (34)

FacilityCityStateZIPSite coordinators
Site Number - 1018MesaArizona85210-
Site Number - 1019Sun CityArizona85351-
Site Number - 1022CovinaCalifornia91722-
Site Number - 1028San LeandroCalifornia94578-
Site Number - 1024TemeculaCalifornia92592-
Site Number - 1033TujungaCalifornia91042-
Site Number - 1023WhittierCalifornia90602-
Site Number - 1020DenverColorado80230-
Site Number - 1015JupiterFlorida33458-
Site Number - 1002MiamiFlorida33143-
Site Number - 1027PlantationFlorida33324-
Site Number - 1005Winter ParkFlorida32789-
Site Number - 1012ZephyrhillsFlorida33542-
Site Number - 1001GainesvilleGeorgia30501-
Site Number - 1034ChicagoIllinois60607-
Site Number - 1006CumberlandMaryland21502-
Site Number - 1007HagerstownMaryland21740-
Site Number - 1031RockvilleMaryland20850-
Site Number - 1008WorcesterMassachusetts01605-
Site Number - 1021Saint Clair ShoresMichigan48081-
Site Number - 1030Kansas CityMissouri64151-
Site Number - 1010SummitNew Jersey07901-
Site Number - 1004CharlotteNorth Carolina28207-
Site Number - 1035StatesvilleNorth Carolina28625-
Site Number - 1000DuncansvillePennsylvania16635-
Site Number - 1016JacksonTennessee38305-
Site Number - 1026MemphisTennessee38119-
Site Number - 1029MurfreesboroTennessee37128-
Site Number - 1037AllenTexas75013-
Site Number - 1017ColleyvilleTexas76034-
Site Number - 1036KatyTexas77494-
Site Number - 1014MesquiteTexas75150-
Site Number - 1013TomballTexas77375-
Site Number - 1025TomballTexas77377-

Find similar trials in Mesa, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Site Number - 1018· Mesa, AZSite Number - 1019· Sun City, AZSite Number - 1022· Covina, CASite Number - 1028· San Leandro, CASite Number - 1024· Temecula, CASite Number - 1033· Tujunga, CA

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