Primary Sjögren's SyndromePhase 2NCT06979531

Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity

A Phase 2 study testing IMVT-1402 in people with Primary Sjögren's Syndrome, run by Immunovant Sciences GmbH at 96 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This is a Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren's disease (SjD). Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Primary Sjögren's Syndrome
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: 180 participants
Where: 96 sitesin 13 countries
Study dates: 30 Jun 2025to Jul 2029
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 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants with a diagnosis of primary SjD for at least 12 months prior to the Screening Visit and meet classification criteria for primary SjS according to the 2016 American College of Rheumatology/ European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome at the time of screening.
Participants with moderate to severe systemic disease activity as determined by a clinESSDAI total score ≥ 5 at the Screening Visit.
Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit.
Participants have residual salivary flow as measured by stimulated whole salivary flow rate ≥ 0.01 milliliters per minute (mL/min) at the Screening Visit.
Additional inclusion criteria are defined in the protocol.

Who cannot join

Participants with a diagnosis of secondary SjD, inadequately treated fibromyalgia, other confirmed connective tissue, rheumatic, or systemic inflammatory autoimmune disease including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, or polymyositis, that in the opinion of the Investigator, is likely to interfere with the ability to assess primary SjD manifestations.
Participants with a history of clinically significant monoclonal gammopathy, including but not limited to monoclonal gammopathy of undetermined significance, history of multiple myeloma or non-Hodgkin's lymphoma, or have an active malignancy or history of malignancy within 5 years prior to the Screening Visit.
Additional exclusion criteria are defined in the protocol.

Trial locations and contacts

96 sites in 13 countries.

Country

City, postcode or hospital

96 sites in 13 countries

United States29 sites

Site Number - 1001
Allen, Texas, 75013
Site Number - 1020
Amarillo, Texas, 79124
Site Number - 1022
Arlington, Texas, 75231
Site Number - 1019
Austin, Texas, 78745
Site Number - 1032
Canton, New York, 13675
Site Number - 1012
Chicago, Illinois, 60607
Site Number - 1027
Covina, California, 91722
Site Number - 1007
El Cajon, California, 91910
Site Number - 1014
Fort Collins, Colorado, 80528
Site Number - 1024
Grapevine, Texas, 76034
Site Number - 1018
Hollywood, Florida, 33024
Site Number - 1011
Houston, Texas, 77030
Site Number - 1010
Houston, Texas, 77407
Site Number - 1015
Jackson, Tennessee, 38305
Site Number - 1021
Jupiter, Florida, 33458
Site Number - 1023
Katy, Texas, 77494
Site Number - 1030
Lake Charles, Louisiana, 77469
Site Number - 1000
Memphis, Tennessee, 38119
Site Number - 1016
Menifee, California, 92586
Site Number - 1002
Miami, Florida, 33143
Site Number - 1006
Mineola, New York, 11501
Site Number - 1028
New Orleans, Louisiana, 70112
Site Number - 1033
Orland Park, Illinois, 60467
Site Number - 1013
Philadelphia, Pennsylvania, 19104
Site Number - 1031
San Antonio, Texas, 78215
Site Number - 1004
Tamarac, Florida, 33321
Site Number - 1025
Tampa, Florida, 33606
Site Number - 1029
Thousand Oaks, California, 91360
Site Number - 1026
Upland, California, 91786

Other trials in United States

Poland16 sites

Site Number - 3008
Bydgoszcz, 85-065
Site Number - 3010
Krakow, 30-363
Site Number - 3014
Lodz, 31-426
Site Number - 3004
Lodz, 91-363
Site Number - 3015
Lublin, 20-412
Site Number - 3005
Lublin, 20-607
Site Number - 3007
Poznan, 60-693
Site Number - 3000
Poznan, 61-397
Site Number - 3011
Siedlce, 08-110
Site Number - 3006
Warsaw, 00-874
Site Number - 3001
Warsaw, 02-637
Site Number - 3003
Warsaw, 02-665
Site Number - 3009
Warsaw, 02-677
Site Number - 3012
Wołomin, 05-200
Site Number - 3002
Wroclaw, 50-556
Site Number - 3013
Wroclaw, 52-416

Other trials in Poland

Argentina8 sites

Site number - 5005
Azcuénaga, Buenos Aires, C1128AAF
Site Number - 5000
Buenos Aires, B1646GHP
Site Number - 5002
Buenos Aires, B1878DVB
Site Number - 5003
Buenos Aires, C1111AAJ
Site Number - 5001
Buenos Aires, C1417EYH
Site number - 5006
Buenos Aires, C1427CCL
Site Number - 5007
Capital Federal, Buenos Aires, C1055AAF
Site Number - 5004
San Miguel de Tucumán, Tucumán Province, T4000

Other trials in Argentina

Chile8 sites

Site Number - 5705
Osorno, 8380456
Site Number - 5700
Santiago, Santiago de Chile, 7500571
Site Number - 5702
Santiago, Santiago de Chile, 7500571
Site Number - 5703
Santiago, Santiago de Chile, 7500587
Site Number - 5701
Santiago, Santiago de Chile, 7510047
Site Number - 5704
Santiago, Santiago de Chile, 8331143
Site Number - 5707
Valdivia, 5110683
Site Number - 5706
Viña del Mar, Valparaiso, 2520000

Other trials in Chile

Germany6 sites

Site Number - 6504
Bad Doberan, 18209
Site Number - 6500
Hamburg, 20095
Site Number - 6501
Hanover, 30625
Site Number - 6503
Heidelberg, 69120
Site number - 6502
Munich, 80336
Site Number - 6505
Munich, 81667

Other trials in Germany

Italy5 sites

Site Number - 6000
Catania, 95121
Site Number - 6001
Milan, 20132
Site Number - 6002
Palermo, 90129
Site Number - 6005
Perugia, 06132
Site Number - 6003
Rome, 00128

Other trials in Italy

Spain5 sites

Site Number - 7103
Bilbao, 48013
Site Number - 7106
Cadiz, 11139
Site Number - 7101
Córdoba, 14004
Site Number - 7102
Mérida, 06800
Site Number - 7104
Valencia, 46010

Other trials in Spain

United Kingdom5 sites

Site Number - 7004
Cambridge, CB2 0QQ
Site Number - 7003
Liverpool, L9 7AL
Site Number - 7002
London, NW3 2QG
Site Number - 7000
Swindon, SN3 6BB
Site Number - 7001
Truro, TR1 3LJ

Other trials in United Kingdom

Hungary4 sites

Site Number - 7550
Budapest, 1027
Site Number - 7552
Hódmezővásárhely, 6800
Site Number - 7551
Kalocsa, 6300
Site Number - 7553
Székesfehérvár, 8000

Other trials in Hungary

Peru3 sites

Site Number - 2403
Lima, 15076
Site Number - 2402
Lima, 15811
Site Number - 2401
Santiago de Surco, Lima region, 15023

Other trials in Peru

Romania3 sites

Site Number - 7502
Brasov, 500283
Site Number - 7500
Bucharest, 011172
Site Number - 7501
Cluj-Napoca, 400000

Other trials in Romania

Canada2 sites

Site Number - 2001
Sherbrooke, Quebec, J1L 0H8
Site Number - 2000
Trois-Rivières, Quebec, G8Z 1Y2

Other trials in Canada

Greece2 sites

Site Number - 3901
Athens, 11521
Site Number - 3900
Athens, 11527

Other trials in Greece

About this study

Official title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity

Read the detailed description

The primary objective is to evaluate the efficacy, safety, and tolerability of IMVT-1402 compared to placebo, as measured by the change from baseline of Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) at Week 24.

The total duration of study participation is expected to be up to 105 weeks for an individual participant.

Conditions: Primary Sjögren's Syndrome
Being tested: IMVT-1402, Placebo
Keywords: Sjogren Disease, IMVT-1402, Imeroprubart

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 groups in NCT06979531
Study group	Role	What they receive
Group 1: IMVT-1402 Dose 1	Experimental	Not described Receives: Drug: IMVT-1402
Group 2: 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.

Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
The clinESSDAI is a tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome.
Measured: Baseline and at Week 24

Secondary outcomes (7)

Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 1 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Measured: Week 24
Change from Baseline in clinESSDAI score at Week 24 for IMVT-1402 Dose 2 compared to Placebo
Measured: Baseline, Week 24
Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 2 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Measured: Week 24
Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 1 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Measured: Week 48
Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 2 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Measured: Week 48
Change from baseline in Physician General Assessment of Disease Activity (PhGA) score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
The PhGA is a measure of the participant's current disease activity as assessed by the physician or another healthcare professional.
Measured: Baseline and at Week 24
Change from baseline in PhGA score at Week 24 for IMVT-1402 Dose 2 compared to Placebo
The PhGA is a measure of the participant's current disease activity as assessed by the physician or another healthcare professional.
Measured: Baseline and at Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 2025Jul 2029

First posted20 May 2025
Study start30 Jun 2025
Primary completionJul 2028 (estimated)
Study completionJul 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary Sjögren's SyndromeStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 180 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06979531
Sponsor's protocol ID: IMVT-1402-2801
Other IDs: 2025-520831-18-00, 2025
Status last verified: Sep 2026
First submitted: 13 May 2025
Last updated: 10 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
ClinicalTrials.gov ID: NCT06979531
Acronym / sponsor ID: IMVT-1402-2801
Conditions: Primary Sjögren's Syndrome
Keywords: Sjogren Disease, IMVT-1402, Imeroprubart
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 180 participants (estimated)
Lead sponsor: Immunovant Sciences GmbHIndustry (pharma, biotech, devices)
Study start: 30 Jun 2025 (actual)
Primary completion: Jul 2028 (estimated)
Study completion: Jul 2029 (estimated)
First posted: 20 May 2025 (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.

Detailed description

The total duration of study participation is expected to be up to 105 weeks for an individual participant.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group 1: IMVT-1402 Dose 1	Experimental	Drug: IMVT-1402
Group 2: IMVT-1402 Dose 2	Experimental	Drug: IMVT-1402
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participants with a diagnosis of primary SjD for at least 12 months prior to the Screening Visit and meet classification criteria for primary SjS according to the 2016 American College of Rheumatology/ European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome at the time of screening.
Participants with moderate to severe systemic disease activity as determined by a clinESSDAI total score ≥ 5 at the Screening Visit.
Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit.
Participants have residual salivary flow as measured by stimulated whole salivary flow rate ≥ 0.01 milliliters per minute (mL/min) at the Screening Visit.
Additional inclusion criteria are defined in the protocol.

Key exclusion criteria (3 listed)

Participants with a diagnosis of secondary SjD, inadequately treated fibromyalgia, other confirmed connective tissue, rheumatic, or systemic inflammatory autoimmune disease including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, or polymyositis, that in the opinion of the Investigator, is likely to interfere with the ability to assess primary SjD manifestations.
Participants with a history of clinically significant monoclonal gammopathy, including but not limited to monoclonal gammopathy of undetermined significance, history of multiple myeloma or non-Hodgkin's lymphoma, or have an active malignancy or history of malignancy within 5 years prior to the Screening Visit.
Additional exclusion criteria are defined in the protocol.

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	Group 1: IMVT-1402 Dose 1, Group 2: IMVT-1402 Dose 2
PlaceboAdministered once weekly by subcutaneous injection	Drug	Placebo

Primary outcome

Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
Time frame: Baseline and at Week 24
The clinESSDAI is a tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome.

7 secondary outcomes

Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 1 compared to Placebo
Time frame: Week 24
Change from Baseline in clinESSDAI score at Week 24 for IMVT-1402 Dose 2 compared to Placebo
Time frame: Baseline, Week 24
Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 2 compared to Placebo
Time frame: Week 24
Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 1 compared to Placebo
Time frame: Week 48
Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 2 compared to Placebo
Time frame: Week 48
Change from baseline in Physician General Assessment of Disease Activity (PhGA) score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
Time frame: Baseline and at Week 24
Change from baseline in PhGA score at Week 24 for IMVT-1402 Dose 2 compared to Placebo
Time frame: Baseline and at Week 24

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 10 Sep 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.

96 sites in 13 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 Primary Sjögren's Syndrome, run by Immunovant Sciences GmbH at 96 sites in 13 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 5 inclusion and 3 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, Poland, Argentina, Chile, Germany and 8 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?

Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo (time frame: Baseline and at Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06979531.

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 10 Sep 2026.