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Tulisokibart

Phase 3

Crohn Disease | Monoclonal antibody | Gastrointestinal |Merck & Company, Inc.|Last Updated: Jul 22, 2026

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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment1,435
FDA Designations
No designations recorded
Clinical trial landscape

Tulisokibart · 12 trials · 11 indications

Phase 3 3Phase 2 7Phase 1 2
NCT06651281Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)Crohn Disease
RECRUITING1,380 Analytics
NCT06430801A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)Crohn's Disease
RECRUITING1,200 Analytics
NCT06052059A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)Ulcerative Colitis
ACTIVE NOT_RECRUITING1,020 Analytics
PHASE3RECRUITING
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Crohn DiseaseUnlock trial analytics
PHASE3RECRUITING
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
Crohn's DiseaseUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
Ulcerative ColitisUnlock trial analytics
Study Endpoints
Primary Endpoints
Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 378 weeks

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 364 weeks

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52
Week 52

The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented.

Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
Week 52

The percentage of participants achieving clinical remission per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented.

Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52
Week 52

The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in Simplified endoscopic score for Crohn's disease (SES-CD) from baseline for study 1 will be presented.

Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Week 12

The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented.

Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Week 12

The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented.

Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12
Week 12

The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for study 1 will be presented.

Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Week 12

The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 2 will be presented.

Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Week 12

The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 2 will be presented.

Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12
Week 12

The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for study 2 will be presented.

Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
Week 12

The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.

Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52
Week 52

The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.

Study 2: Percentage of Participants Achieving Clinical Remission Per MMS at Week 12
Week 12

The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.

Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 16
Week 16

ACR20 response is defined as a ≥20% improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints (0= absent; 1= present) and b) ≥20% improvement in ≥3 of 5 components: i) Health Assessment Questionnaire Disability Index (HAQ-DI) (0=without any difficulty; 3= unable to do; a higher score=worse disability); ii) Physician Global Assessment of Disease Activity (PGA) (0= not active to 10= very active; a higher score= more active disease); iii) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active; a higher score= more active disease); iv) Patient assessment of Pain Severity (0= no pain to 10= most severe pain; a higher score = more pain); v) High-sensitivity C-reactive protein (hsCRP) blood values (lower value indicates less inflammation).

Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
Week 12

The ACR20 response is a composite measure to evaluate disease activity in RA. ACR20 response is defined as a ≥20% improvement in: a) swollen joint count (66 joints) and tender joint count (68 joints) (0= Absent; 1= Present) and b) ≥20% improvement in ≥3 of the following 5 assessments and questionnaires: i) Health Assessment Questionnaire Disability Index (HAQ-DI) (0=without any difficulty; 3= unable to do) a higher score=worse disability, ii) Physician Global Assessment of Disease Activity (PGA) (0= not active to 10= very active) a higher score= more active disease; iii) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active) a higher score= more active disease; iv) Patient assessment of Pain Severity (0= no pain to 10= most severe pain) a higher score = more pain; v) High-sensitivity C-reactive protein (hsCRP) serum values, a lower value indicates less inflammation. The proportion of participants with ACR20 response at Week 12 will be presented.

Percentage of Participants Achieving Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 16
Week 16

ASAS 40 is defined as a relative improvement of ≥40% and an absolute improvement of ≥2 units from baseline in ≥3 of 4 domains, with no deterioration in the fourth domain. The 4 domains include Patient Global Assessment (PtGA), total spinal pain, physical function, and morning stiffness. Each domain is measured on a 10-point numeric scale from 0 = no disease symptoms/impact to 10 = extreme disease symptoms/impact, with a higher score indicating more severe impairment.

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at Week 16
Week 16

The percentage of participants with ≥50% reduction in total abscesses and inflammatory nodules (AN) count with no increase in abscess count, and no increase in draining tunnels (ie, HiSCR50) will be reported.

Number of Participants who Experience a Serious Adverse Event (SAE)
Up to Week 50

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who experience an SAE will be reported.

Number of Participants who Discontinue due to an AE
Up to Week 50

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who discontinue due to an AE will be reported.

Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at Week 50
Baseline and up to Week 50

FVC, as measured in milliliters by spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible.

Adverse Events
Up to approximately 18 weeks

Number of participants who experienced treatment-emergent adverse events (AEs)

Serious Adverse Events
Up to approximately 18 weeks

Number of participants who experienced serious adverse events (SAEs)

Adverse Events Leading to Discontinuation
Up to approximately 12 weeks

Number of participants who experienced AEs leading to discontinuation

Endoscopic Improvement
Week 12

Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease \[SES-CD\] ≥ 50% from Baseline)

Percentage of Participants in Cohort 1 Achieving Clinical Remission
Baseline and Week 12

The 3-component Modified Mayo Score (MMS) ranges from 0 to 9 and is composed of endoscopic assessment, rectal bleeding (RB), and stool frequency (SF) subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical remission is defined as endoscopic subscore of 0 or 1, RB subscore of 0, and SF subscore of 0 or 1 and not greater than baseline. Per protocol participants in Cohort 1 were analyzed for this outcome measure.

Percentage of Participants Who Experienced an Adverse Event (AE)
Up to ~14 weeks

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. Reported adverse experiences used the Common Terminology for Adverse Events (CTCAE) Version 4.0. Per protocol, adverse events are reported by treatment with tulisokibart or placebo regardless of assigned cohort. Participants received identical treatment regiments regardless of cohort. The percentage of participants who experienced at least one AE is reported.

Percentage of Participants Who Discontinued Due to an AE
Up to ~14 weeks

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. Reported adverse experiences used the Common Terminology for Adverse Events (CTCAE) Version 4.0. Per protocol, adverse events are reported by treatment with tulisokibart or placebo regardless of assigned cohort. Participants received identical treatment regiments regardless of cohort. The percentage of participants who discontinued due to an AE is reported.

Percentage of Participants Who Had One or More Serious Adverse Events
Up to ~14 weeks

Reported adverse experiences used the Common Terminology for Adverse Events (CTCAE) Version 4.0. Serious adverse events are defined as: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL), Life-threatening consequences; urgent intervention indicated, and death. Per protocol, adverse events are reported by treatment with tulisokibart or placebo regardless of assigned cohort. Participants received identical treatment regiments regardless of cohort. The percentage of participants experiencing a serious AE are presented.

Area Under the Curve from Time 0 to Infinity (AUC0-inf): Treatment A
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)

Blood will be collected at pre-specified time points to determine the AUC0-inf of tulisokibart. AUC0-inf is defined as the area under concentration-time curve of tulisokibart from time zero to infinity.

Area Under the Curve from Time 0 to Last Measurable Concentration (AUC0- last): Treatment A
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)

Blood will be collected at pre-specified time points to determine the AUC0-last of tulisokibart. AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of tulisokibart.

Maximum Plasma Concentration (Cmax): Treatment A
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)

Blood will be collected at pre-specified time points to determine the Cmax of tulisokibart. Cmax is defined as the maximum concentration of tulisokibart reached.

Time to Cmax (Tmax): Treatment A
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)

Blood will be collected at pre-specified time points to determine the Tmax of tulisokibart. Tmax is defined as the time to maximum concentration of tulisokibart reached.

Clearance after Nonintravenous Administration (CL/F): Treatment A
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)

Blood will be collected at pre-specified time points to determine the CL/V of tulisokibart. CL/F is the rate at which the tulisokibart is completely removed from plasma.

Volume of Distribution (V/F): Treatment A
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)

Blood will be collected at pre-specified time points to determine the V/F of tulisokibart. V/F is the volume of distribution of tulisokibart.

Half Life (t1/2): Treatment A
Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)

Blood will be collected at pre-specified time points to determine the t1/2 of tulisokibart. t1/2 is defined as the time required to divide plasma concentration of tulisokibart by half.

Number of Participants Who Discontinued the Study Due to AEs
Up to 99 days

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Tulisokibart
Predose and at designated timepoints (up to 99 days postdose)

Blood samples will be collected to determine the AUC0-last of tulisokibart.

Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Tulisokibart
Predose and at designated timepoints (up to 99 days postdose)

Blood samples will be collected to determine the AUC0-inf of tulisokibart.

Maximum Concentration (Cmax) of Tulisokibart
Predose and at designated timepoints (up to 99 days postdose)

Blood samples will be collected to determine the Cmax of tulisokibart.

Time to Maximum Concentration (Tmax) of Tulisokibart
Predose and at designated timepoints (up to 99 days postdose)

Blood samples will be collected to determine the Tmax of tulisokibart.

Apparent Terminal Half-life (t1/2) of Tulisokibart
Predose and at designated timepoints (up to 99 days postdose)

Blood samples will be collected to determine the t1/2 of tulisokibart.

Apparent Clearance (CL/F) of Tulisokibart
Predose and at designated timepoints (up to 99 days postdose)

Blood samples will be collected to determine the CL/F of tulisokibart.

Apparent Volume of Distribution (Vz/F) of Tulisokibart
Predose and at designated timepoints (up to 99 days postdose)

Blood samples will be collected to determine the Vz/F of tulisokibart.

Secondary Endpoints
Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Week 364
Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score
Week 364
Percentage of Participants with Crohn's Disease With Endoscopic Remission Per Simplified Endoscopic Score for Crohn's Disease (SES-CD)
Week 364
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1: Low Dose UnblindedEXPERIMENTALParticipants receive a low dose subcutaneous (SC) tulisokibart regimen.
Group 2: High Dose UnblindedEXPERIMENTALParticipants receive a high dose SC tulisokibart regimen.
Group 3: High Dose BlindedEXPERIMENTALParticipants receive a blinded high dose SC tulisokibart regimen.
Group 4: Low Dose BlindedEXPERIMENTALParticipants receive a blinded low dose SC tulisokibart regimen.
Study 1: High Dose Induction, High Dose MaintenanceEXPERIMENTALParticipants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.
Study 1: High Dose Induction, Low Dose MaintenanceEXPERIMENTALParticipants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Study 1: Low Dose Induction, Low Dose MaintenanceEXPERIMENTALParticipants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Study 1: PlaceboPLACEBO_COMPARATORParticipants receive IV placebo, followed by an SC placebo regimen.
Study 1: High Dose ExtensionEXPERIMENTALParticipants receive a high dose SC tulisokibart regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Study 1: Low Dose ExtensionEXPERIMENTALParticipants receive a low dose SC tulisokibart and placebo regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Study 2: High Dose InductionEXPERIMENTALParticipants receive high dose IV tulisokibart.
Study 2: Low Dose InductionEXPERIMENTALParticipants receive low dose IV tulisokibart.
Study 2: PlaceboPLACEBO_COMPARATORParticipants receive IV placebo.
Study 2: High Dose ExtensionEXPERIMENTALParticipants receive a high dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Study 2: Low Dose ExtensionEXPERIMENTALParticipants receive a low dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
High-Dose RegimenEXPERIMENTALParticipants receive a high dose of tulisokibart.
Medium-Dose RegimenEXPERIMENTALParticipants receive a medium dose of tulisokibart.
Low-Dose RegimenEXPERIMENTALParticipants receive a low dose of tulisokibart and are rerandomized at Week 16 to a medium or high dose of tulisokibart.
Placebo RegimenPLACEBO_COMPARATORParticipants receive a matched placebo dose and are rerandomized at Week 16 to a medium or high dose of tulisokibart.
High-dose tulisokibartEXPERIMENTALParticipants receive background therapy of methotrexate (MTX) PLUS a high dose of tulisokibart
Medium-dose tulisokibartEXPERIMENTALParticipants receive background therapy of MTX PLUS a medium dose of tulisokibart.
Low-dose tulisokibartEXPERIMENTALParticipants receive background therapy of MTX PLUS a low dose of tulisokibart and are rerandomized at week 12 to a medium or high dose of tulisokibart.
PlaceboPLACEBO_COMPARATORParticipants receive background therapy of MTX PLUS a dose-matched tulisokibart placebo and are re-randomized at week 12 to a medium or high dose of tulisokibart.
Arm 1: High DoseEXPERIMENTALParticipants receive a high dose tulisokibart regimen.
Arm 2: Medium DoseEXPERIMENTALParticipants receive a medium dose tulisokibart regimen.
Arm 3: Low DoseEXPERIMENTALParticipants receive a low dose tulisokibart regimen.
Arm 4: PlaceboPLACEBO_COMPARATORParticipants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16.
TulisokibartEXPERIMENTALTulisokibart IV administered by IV infusion
Induction TulisokibartEXPERIMENTALDuring the 12-week Induction Period, participants receive tulisokibart administered by intravenous (IV) infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10.
OLE Tulisokibart 100 mgEXPERIMENTALAfter completing the 12-week Induction Period, eligible participants have the option to enter the OLE Period for up to 170 weeks. Participants are randomized into the OLE Period to receive 100 mg tulisokibart by IV infusion every 4 weeks (q4w). At the discretion of the investigator, participants may titrate up to 250 mg Q4W if disease activity is not adequately controlled.
OLE Tulisokibart 250 mgEXPERIMENTALAfter completing the 12-week Induction Period, eligible participants have the option to enter the OLE Period for up to 170 weeks. Participants are randomized into the OLE Period to receive 250 mg tulisokibart by IV infusion q4w.
Cohort 1 TulisokibartEXPERIMENTALParticipants who are CDx+ and CDx- will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Cohort 1 PlaceboPLACEBO_COMPARATORParticipants who are CDx+ and CDx- will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Cohort 2 TulisokibartEXPERIMENTALParticipants who are CDx+ will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0 and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Cohort 2 PlaceboPLACEBO_COMPARATORParticipants who are CDx+ will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Treatment AEXPERIMENTALSingle dose delivered subcutaneously (SC) with an autoinjector
Treatment BEXPERIMENTALSingle dose of concentration A delivered SC with syringe and vial
Treatment CEXPERIMENTALSingle dose of concentration B delivered SC with syringe and vial
Tulisokibart Dose 1 Treatment Subcutaneous (SC) InjectionEXPERIMENTALParticipants will receive a single SC injection dose of tulisokibart at dose 1 on Day 1.
Placebo SC InjectionPLACEBO_COMPARATORParticipants will receive a single SC injection dose of placebo at on Day 1.
Tulisokibart Dose 1 Intravenous (IV) InfusionEXPERIMENTALParticipants will receive a single IV infusion dose of tulisokibart at dose 1 on Day 1.
Tulisokibart Dose 2 IV InfusionEXPERIMENTALParticipants will receive a single IV infusion dose of tulisokibart at dose 2 on Day 1.
Tulisokibart Dose 3 IV InfusionEXPERIMENTALParticipants will receive a single IV infusion dose of tulisokibart at dose 3 on Day 1.
Placebo IV InfusionPLACEBO_COMPARATORParticipants will receive a single IV infusion dose of placebo on Day 1.
Interventions
NameTypeDescription
TulisokibartDRUGHumanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Placebo to tulisokibartDRUGPlacebo matching SC tulisokibart
IV TulisokibartDRUGHumanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
SC TulisokibartDRUGHumanized monoclonal antibody that binds human TL1A, administered subcutaneously
IV PlaceboOTHERPlacebo matching IV tulisokibart
SC PlaceboOTHERPlacebo matching SC tulisokibart
PlaceboDRUGSubcutaneous administration
MethotrexateDRUGBackground Therapy - SC injection or oral administration. Per protocol, parenteral administration is allowed.
Companion diagnostic ( CDx)DIAGNOSTIC_TESTCDx+ or CDx-
Companion Diagnostic (CDx)DIAGNOSTIC_TESTPRA023 CDx Genotyping Assay
Companion Diagnostic (CDx) TestingDEVICEPRA023 CDx Genotyping Assay
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Eligibility Criteria
Age Range16 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC * The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study * A part...

Countries:United StatesCzechiaFranceGeorgiaHungaryPolandUnited KingdomAustraliaAustriaBelgiumBrazilCanadaChileChinaColombiaCroatiaDenmarkDominican RepublicFinlandGermanyGreeceHong KongIrelandIsraelItalyJapanLatviaLithuaniaMalaysiaMexicoNetherlandsNew ZealandPeruPortugalRomaniaSaudi ArabiaSerbiaSingaporeSlovakiaSouth AfricaSouth KoreaSpainSwedenSwitzerlandTaiwanTurkey (Türkiye)UkraineArgentinaBulgariaNorway
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