Clinical trial NCT06754462: A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Anticitrullinated protein autoantibodies
Difficult-to-treat
Anti-FcRn
IMVT-1402 Autoimmune Diseases
Lead sponsor: Immunovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2024-12-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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). 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.

Detailed description: The study consists of several periods. During the Screening Period (5 weeks) participants will undergo screening procedures to determine eligibility. In Period 1 (Open-Label Treatment), all eligible participants will receive open-label treatment with IMVT-1402 at a dose of 600 mg subcutaneous (SC) once weekly (QW) for 16 weeks. Participants who meet the ACR20 response criteria at Weeks 14 and 16 will be randomized in a 1:1:1 ratio to receive blinded treatment with either IMVT-1402 600 mg SC QW, IMVT-1402 300 mg SC QW, or placebo SC QW for 12 weeks in Period 2 (Randomized Withdrawal). Eligible participants who complete Period 2 at Week 28 will have the option to receive IMVT-1402 for an additional 48 weeks in Period 3 (Long -Term Extension). A follow-up visit will occur 4 weeks after the last dose of study treatment to monitor safety.

The primary endpoint of the study is the proportion of participants achieving an ACR20 response at the end of Period 2. Secondary objectives include evaluating the safety and tolerability of IMVT-1402, as well as its effects on other efficacy measures. This study aims to provide valuable data on the use of IMVT-1402 in treating adults with active, difficult-to-treat, ACPR-positive RA.

Eligibility criteria: 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 TJC and ≥ 6/66 SJC at both Screening and Baseline visits.
* C-reactive protein ≥ 1.5 × upper limit of normal (ULN) at Screening Visit.
* DAS28-CRP \> 4.1 at the Screening Visit.
* Elevated immunoglobulin G (IgG) + ACPA at the Screening Visit.
* Inadequate response to at least 2 classes of biologic/targeted synthetic 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 non-immunosuppressive 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, more specific exclusion criteria are defined in the protocol.

Primary outcomes:
measure: For participants in Period 2: proportion of participants who maintain ACR20 response at Week 28 compared to baseline from Period 1
timeFrame: From baseline to Week 28
Secondary outcomes:
measure: For participants in Period 2, change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28
timeFrame: Week 16 to Week 28
measure: For participants in Period 2, change in Simplified Disease Activity Index (SDAI) score from Week 16 to Week 28
timeFrame: Week 16 to Week 28
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Site Number - 1003
state: Alabama
city: Mesa
country: United States
facility: Site Number - 1018
state: Arizona
city: Sun City
country: United States
facility: Site Number - 1019
state: Arizona
city: Covina
country: United States
facility: Site Number - 1022
state: California
city: Fresno
country: United States
facility: Site Number - 1032
state: California
city: San Leandro
country: United States
facility: Site Number - 1028
state: California
city: Temecula
country: United States
facility: Site Number - 1024
state: California
city: Tujunga
country: United States
facility: Site Number - 1033
state: California
city: Whittier
country: United States
facility: Site Number - 1023
state: California
city: Denver
country: United States
facility: Site Number - 1020
state: Colorado
city: Jupiter
country: United States
facility: Site Number - 1015
state: Florida
city: Miami
country: United States
facility: Site Number - 1002
state: Florida
city: Plantation
country: United States
facility: Site Number - 1027
state: Florida
city: Winter Park
country: United States
facility: Site Number - 1005
state: Florida
city: Zephyrhills
country: United States
facility: Site Number - 1012
state: Florida
city: Gainesville
country: United States
facility: Site Number - 1001
state: Georgia
city: Cumberland
country: United States
facility: Site Number - 1006
state: Maryland
city: Hagerstown
country: United States
facility: Site Number - 1007
state: Maryland
city: Worcester
country: United States
facility: Site Number - 1008
state: Massachusetts
city: Saint Clair Shores
country: United States
facility: Site Number - 1021
state: Michigan
city: Kansas City
country: United States
facility: Site Number - 1030
state: Missouri
city: Summit
country: United States
facility: Site Number - 1010
state: New Jersey
city: Charlotte
country: United States
facility: Site Number - 1004
state: North Carolina
city: Duncansville
country: United States
facility: Site Number - 1000
state: Pennsylvania
city: Jackson
country: United States
facility: Site Number - 1016
state: Tennessee
city: Memphis
country: United States
facility: Site Number - 1026
state: Tennessee
city: Murfreesboro
country: United States
facility: Site Number -1029
state: Tennessee
city: Colleyville
country: United States
facility: Site Number - 1017
state: Texas
city: Mesquite
country: United States
facility: Site Number - 1014
state: Texas
city: Tomball
country: United States
facility: Site Number - 1013
state: Texas
city: Tomball
country: United States
facility: Site Number - 1025
state: Texas
city: Plovdiv
country: Bulgaria
facility: Site Number - 5603
city: Plovdiv
country: Bulgaria
facility: Site Number - 5605
city: Plovdiv
country: Bulgaria
facility: Site Number - 5602
city: Ruse
country: Bulgaria
facility: Site Number - 5604
city: Sevlievo
country: Bulgaria
facility: Site Number - 5606
city: Sofia
country: Bulgaria
facility: Site Number - 5600
city: Sofia
country: Bulgaria
facility: Site Number - 5601
city: Brno
country: Czechia
facility: Site Number - 3204
city: Ostrava
country: Czechia
facility: Site Number - 3202
city: Praha 2 Nové Město
country: Czechia
facility: Site Number - 3203
city: Uherské Hradiště
country: Czechia
facility: Site Number - 3201
city: Zlín
country: Czechia
facility: Site Number - 3200
city: Tbilisi
country: Georgia
facility: Site Number - 8002
city: Tbilisi
country: Georgia
facility: Site Number - 8000
city: Tbilisi
country: Georgia
facility: Site Number - 8001
city: Tbilisi
country: Georgia
facility: Site Number - 8003
city: Hamburg
country: Germany
facility: Site Number - 6500
city: Ratingen
country: Germany
facility: Site Number - 6501
city: Budapest
country: Hungary
facility: Site Number - 7554
city: Budapest
country: Hungary
facility: Site Number - 7555
city: Hódmezővásárhely
country: Hungary
facility: Site Number - 7550
city: Kecskemét
country: Hungary
facility: Site Number - 7553
city: Székesfehérvár
country: Hungary
facility: Site Number - 7551
city: Veszprém
country: Hungary
facility: Site Number - 7552
city: Białystok
country: Poland
facility: Site Number - 3001
city: Białystok
country: Poland
facility: Site Number - 3005
city: Elbląg
country: Poland
facility: Site Number - 3007
city: Nadarzyn
country: Poland
facility: Site Number - 3006
city: Poznań
country: Poland
facility: Site Number - 3008
city: Poznań
country: Poland
facility: Site Number - 3000
city: Sochaczew
country: Poland
facility: Site Number - 3003
city: Warszawa
country: Poland
facility: Site Number - 3004
city: Wrocław
country: Poland
facility: Site Number - 3002
city: Braşov
country: Romania
facility: Site Number - 7500
city: Râmnicu Vâlcea
country: Romania
facility: Site Number - 7501
city: Bilbao
country: Spain
facility: Site Number - 7101
city: Málaga
country: Spain
facility: Site Number - 7102
city: Sevilla
country: Spain
facility: Site Number - 7100
city: Edinburgh
country: United Kingdom
facility: Site Number - 7000
city: London
country: United Kingdom
facility: Site Number - 7001
city: North Shields
country: United Kingdom
facility: Site Number -7002
city: Wolverhampton
country: United Kingdom
facility: Site Number - 7003
Study officials:
References: