Rheumatoid ArthritisPhase 2NCT06754462
A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis
A Phase 2 study testing IMVT-1402 in people with Rheumatoid Arthritis, run by Immunovant Sciences GmbH at 83 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- IMVT-1402
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 83 sitesin 11 countries
- Study dates
- 10 Jan 2025to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
83 sites in 11 countries.
83 sites in 11 countries
United States34 sites
Site Number - 1037
Allen, Texas, 75013
Site Number - 1004
Charlotte, North Carolina, 28207
Site Number - 1034
Chicago, Illinois, 60607
Site Number - 1017
Colleyville, Texas, 76034
Site Number - 1022
Covina, California, 91722
Site Number - 1006
Cumberland, Maryland, 21502
Site Number - 1020
Denver, Colorado, 80230
Site Number - 1000
Duncansville, Pennsylvania, 16635
Site Number - 1001
Gainesville, Georgia, 30501
Site Number - 1007
Hagerstown, Maryland, 21740
Site Number - 1016
Jackson, Tennessee, 38305
Site Number - 1015
Jupiter, Florida, 33458
Site Number - 1030
Kansas City, Missouri, 64151
Site Number - 1036
Katy, Texas, 77494
Site Number - 1026
Memphis, Tennessee, 38119
Site Number - 1018
Mesa, Arizona, 85210
Site Number - 1014
Mesquite, Texas, 75150
Site Number - 1002
Miami, Florida, 33143
Site Number - 1029
Murfreesboro, Tennessee, 37128
Site Number - 1027
Plantation, Florida, 33324
Site Number - 1031
Rockville, Maryland, 20850
Site Number - 1021
Saint Clair Shores, Michigan, 48081
Site Number - 1028
San Leandro, California, 94578
Site Number - 1035
Statesville, North Carolina, 28625
Site Number - 1010
Summit, New Jersey, 07901
Site Number - 1019
Sun City, Arizona, 85351
Site Number - 1024
Temecula, California, 92592
Site Number - 1013
Tomball, Texas, 77375
Site Number - 1025
Tomball, Texas, 77377
Site Number - 1033
Tujunga, California, 91042
Site Number - 1023
Whittier, California, 90602
Site Number - 1005
Winter Park, Florida, 32789
Site Number - 1008
Worcester, Massachusetts, 01605
Site Number - 1012
Zephyrhills, Florida, 33542
Poland9 sites
Site Number - 3005
Bialystok, 15-879
Site Number - 3007
Elblag, 82-300
Site Number - 3009
Lublin, 20-607
Site Number - 3006
Nadarzyn, 05-830
Site Number - 3008
Poznan, 60-848
Site Number - 3000
Poznan, 61-397
Site Number - 3003
Sochaczew, 96-500
Site Number - 3004
Warsaw, 02-665
Site Number - 3002
Wroclaw, 53-673
Bulgaria7 sites
Site Number - 5603
Plovdiv, 4000
Site Number - 5605
Plovdiv, 4002
Site Number - 5602
Plovdiv, 4004
Site Number - 5604
Rousse, 7000
Site Number - 5606
Sevlievo, 5400
Site Number - 5600
Sofia, 1336
Site Number - 5601
Sofia, 1680
Argentina6 sites
Site Number - 5003
Buenos Aires, 1417
Site Number - 5001
Buenos Aires, 1425
Site Number -5004
Buenos Aires, C1046
Site Number - 5002
Buenos Aires, C1118AAF
Site Number - 5005
Buenos Aires, C1180AAX
Site Number - 5000
San Miguel de Tucumán, 4000
Hungary6 sites
Site Number - 7554
Budapest, 1027
Site Number - 7555
Budapest, 1027
Site Number - 7550
Hódmezővásárhely, 6800
Site Number - 7553
Kecskemét, 6000
Site Number - 7551
Székesfehérvár, 8000
Site Number - 7552
Veszprém, 8200
Czechia5 sites
Site Number - 3204
Brno, 638 00
Site Number - 3202
Ostrava, 702 00
Site Number - 3203
Praha 2 Nove Mesto, 128 50
Site Number - 3201
Uherské Hradiště, 686 01
Site Number - 3200
Zlín, 760 01
Spain4 sites
Site Number - 7104
Barcelona, 08208
Site Number - 7101
Bilbao, 48013
Site Number - 7102
Málaga, 29009
Site Number - 7100
Seville, 41009
United Kingdom4 sites
Site Number - 7000
Edinburgh, EH4 2XU
Site Number - 7001
London, SE5 9RJ
Site Number -7002
North Shields, NE29 8NH
Site Number - 7003
Wolverhampton, WV10 0QP
Georgia3 sites
Site Number - 8000
Tbilisi, 0159
Site Number - 8001
Tbilisi, 0160
Site Number - 8003
Tbilisi, 0186
Romania3 sites
Site Number - 7500
Brasov, 500283
Site Number - 7502
Bucharest, 020475
Site Number - 7501
Râmnicu Vâlcea, 240636
Germany2 sites
Site Number - 6500
Hamburg, 20095
Site Number - 6501
Ratingen, 40878
About this study
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
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).
Read the detailed description
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- IMVT-1402, Placebo
- Keywords
- Rheumatoid Arthritis, Anticitrullinated protein autoantibodies, Difficult-to-treat, Anti-FcRn, IMVT-1402, Autoimmune Diseases, Imeroprubart
- Medical subject headings
- Arthritis, Rheumatoid, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMVT-1402Drug
Administered once weekly by subcutaneous injection.
PlaceboDrug
Administered once weekly by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| IMVT-1402 Dose 1 | Experimental | Not described Receives: Drug: IMVT-1402 |
| IMVT-1402 Dose 2 | Experimental | Not described Receives: Drug: IMVT-1402 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who maintain ACR20 response at Week 28
Measured: Week 28
Secondary outcomes (2)
Change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28
Measured: Week 16 to Week 28
Change in Simplified Disease Activity Index (SDAI) score from Week 16 to Week 28
Measured: Week 16 to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start10 Jan 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754462
- Sponsor's protocol ID
- IMVT-1402-2601
- Other IDs
- 2024-515973-82-00
- Status last verified
- Apr 2026
- First submitted
- 24 Dec 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06754462
- Acronym / sponsor ID
- IMVT-1402-2601
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Anticitrullinated protein autoantibodies, Difficult-to-treat, Anti-FcRn, IMVT-1402, Autoimmune Diseases, Imeroprubart
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Immunovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMVT-1402 Dose 1 | Experimental | Drug: IMVT-1402 |
| IMVT-1402 Dose 2 | Experimental | Drug: IMVT-1402 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMVT-1402Administered once weekly by subcutaneous injection. | Drug | IMVT-1402 Dose 1, IMVT-1402 Dose 2 |
| PlaceboAdministered once weekly by subcutaneous injection. | Drug | Placebo |
Primary outcome
Proportion of participants who maintain ACR20 response at Week 28
Time frame: Week 28
2 secondary outcomes
Change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28
Time frame: Week 16 to Week 28
Change in Simplified Disease Activity Index (SDAI) score from Week 16 to Week 28
Time frame: Week 16 to Week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
83 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMVT-1402 in people with Rheumatoid Arthritis, run by Immunovant Sciences GmbH at 83 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United States, Poland, Bulgaria, Argentina, Hungary and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who maintain ACR20 response at Week 28 (time frame: Week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.