Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 7240-006 | Other Identifier | MSD | |
| 2023-509742-35-00 | Registry Identifier | EU CT | |
| U1111-1309-6108 | Registry Identifier | UTN | |
| PR200-103 | Other Identifier | Prometheus Biosciences | |
| 2021-000092-37 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and efficacy of tulisokibart (MK-7240) in participants with moderately to severely active Crohn's Disease.
After the completion of the 12-week Induction Period, eligible participants have the option to enter an Open-label Extension (OLE) Period for up to 170 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction Tulisokibart | Experimental | During the 12-week Induction Period, participants receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1 of Week 0, and 500 mg on Day 1 of Weeks 2, 6, and 10. |
|
| OLE Tulisokibart 100 mg | Experimental | After 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). |
|
| OLE Tulisokibart 250 mg | Experimental | After 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tulisokibart | Biological | Tulisokibart administered by IV infusion as directed by the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants who experienced treatment-emergent adverse events (AEs) | Week 12 |
| Serious Adverse Events | Number of participants who experienced serious adverse events (SAEs) | Week 12 |
| Adverse Events Leading to Discontinuation | Number of participants who experienced AEs leading to discontinuation | Week 12 |
| Endoscopic Improvement | Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease [SES-CD] ≥ 50% from Baseline) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Remission | Number of participants achieving clinical remission, as defined by Crohn's disease activity index [CDAI] score < 150 | Week 12 |
| Endoscopic and Clinical Improvement | Number of participants who achieved a decrease in SES-CD ≥ 50% AND reduction in CDAI ≥ 100 points from Baseline or CDAI<150 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prometheus Biosciences Selected Site | Los Angeles | California | 90045 | United States | ||
| Prometheus Biosciences Selected Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40456235 | Derived | Feagan BG, Sands BE, Siegel CA, Dubinsky MC, Longman RS, Sabino J, Laurent O, Luo A, Lu J, Nguyen DD, Munoz-Elias EJ, Llewellyn H, Wang Y, Jang I, Bilsborough J, Marchelletta R, Towfic F, Yen M, Anderson JK, DuVall A, Kierkus J, Woynarowski M, Al Kharrat H, Targan SR, McGovern DPB. Safety and efficacy of the anti-TL1A monoclonal antibody tulisokibart for Crohn's disease: a phase 2a induction trial. Lancet Gastroenterol Hepatol. 2025 Aug;10(8):715-725. doi: 10.1016/S2468-1253(25)00071-8. Epub 2025 May 30. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PRA023 | Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2022 | Sep 11, 2023 |
Not provided
Participants enrolling in the study are initially allocated to a single treatment arm in the Induction Period. Eligible participants who complete the Induction Period and responded to tulisokibart treatment may then enter the optional 170-week OLE Period. Participants who enter the OLE Period are randomized to one of two tulisokibart treatment arms.
Not provided
Not provided
Not provided
Not provided
|
| Companion Diagnostic (CDx) | Diagnostic Test | PRA023 CDx Genotyping Assay |
|
| Week 12 |
| Number of Participants Achieving a Composite Response | Composite response is defined as a decrease by at least 50% in hsCRP or fecal calprotectin from baseline and a reduction of either CDAI ≥ 100 points from Baseline or CDAI<150 in subjects with at least one elevated biomarker at baseline. | Week 12 |
| Normalization of C-reactive Protein | Number of participants with normalization of hsCRP (as defined by hsCRP < 5 mg/L), among subjects with elevated concentrations at Baseline, at Week 12 | Week 12 |
| Normalization of Fecal Calprotectin | Number of participants with normalization of fecal calprotectin (fecal calprotectin < 250 ug/g), among subjects with elevated concentrations at Baseline, at Week 12 | Week 12 |
| Clinical Response | Clinical response is defined as either a reduction of either CDAI ≥ 100 points from Baseline or CDAI<150. | Week 12 |
| Two Component Patient-reported Outcome (PRO-2) Remission | Number of subjects with PRO-2 remission (defined as average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than Baseline) at Week 12. | Week 12 |
| Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD) | Assessment of change in simple endoscopy score for Crohn's Disease (SES-CD) from Baseline. Measure Description: The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. | Baseline and Week 12 |
| Serum Concentration of PRA023 (MK-7240) | Blood samples were obtained for PK analysis of the serum concentration of PRA023 at week 12. | Week 12 |
| Number of Participants Positive for Anti-drug Antibody (ADA) | Blood samples were collected for the determination of anti-PR023 antibodies based on confirmatory assay. The number of participants with confirmed positive anti-PR023 antibodies results at any visit during the study is presented. | Up to approximately 12 weeks |
| Number of Participants With Positive Neutralizing Anti-Bodies (NAB) | Blood samples were collected for the determination of NAB. The number of participants with positive NAB results at any visit during the study is presented. | Up to approximately 12 weeks |
| Los Angeles |
| California |
| 90048 |
| United States |
| Prometheus Biosciences Selected Site | Liberty | Kansas | 64098 | United States |
| Prometheus Biosciences Selected Site | Chesterfield | Michigan | 48047 | United States |
| Prometheus Biosciences Selected Site | Ypsilanti | Michigan | 48197 | United States |
| Prometheus Biosciences Selected Site | St Louis | Missouri | 63141 | United States |
| Prometheus Biosciences Selected Site | Lebanon | New Hampshire | 03756 | United States |
| Prometheus Biosciences Selected Site | New York | New York | 10065 | United States |
| Prometheus Biosciences Selected Site | Garland | Texas | 75044 | United States |
| Prometheus Biosciences Selected Site | Lubbock | Texas | 79410 | United States |
| Prometheus Biosciences Selected Site | Lubbock | Texas | 79424 | United States |
| Prometheus Biosciences Selected Site | San Antonio | Texas | 78229 | United States |
| Prometheus Biosciences Selected Site | Southlake | Texas | 78229 | United States |
| Prometheus Biosciences Selected Site | Tyler | Texas | 75702 | United States |
| Prometheus Biosciences Selected Site | Bellevue | Washington | 98004 | United States |
| Prometheus Biosciences Selected Site | Tacoma | Washington | 98405 | United States |
| Prometheus Biosciences Selected Site | Bankstown | New South Wales | 2146 | Australia |
| Prometheus Biosciences Selected Site | Woolloongabba | Queensland | 4102 | Australia |
| Prometheus Biosciences Selected Site | Adelaide | South Australia | 5000 | Australia |
| Prometheus Biosciences Selected Site | Leuven | 3000 | Belgium |
| Prometheus Biosciences Selected Site | Liège | 4000 | Belgium |
| Prometheus Biosciences Selected Site | London | Ontario | N6A 5W9 | Canada |
| Prometheus Biosciences Selected Site | Brno | Czechia |
| Prometheus Biosciences Selected Site | Slaný | 274 01 | Czechia |
| Prometheus Biosciences Selected Site | Clichy | 92110 | France |
| Prometheus Biosciences Selected Site | Nice | 06202 | France |
| Prometheus Biosciences Selected Site | Saint-Priest-en-Jarez | 42270 | France |
| Prometheus Biosciences Selected Site | Vandœuvre-lès-Nancy | 54511 | France |
| Prometheus Biosciences Selected Site | Tbilisi | Georgia |
| Prometheus Biosciences Selected Center | Krakow | 31-501 | Poland |
| Prometheus Biosciences Selected Site | Rzeszów | 35-326 | Poland |
| Prometheus Biosciences Selected Site | Sopot | 81-756 | Poland |
| Prometheus Biosciences Selected Site | Torun | 87-100 | Poland |
| Prometheus Biosciences Selected Center | Warsaw | 00-635 | Poland |
| Prometheus Biosciences Selected Site | Warsaw | 03-580 | Poland |
| Prometheus Biosciences Selected Center | Warsaw | 52-416 | Poland |
| Prometheus Biosciences Selected Site | Wroclaw | 52-416 | Poland |
| Plain Language Summary | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PRA023 | Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||||||
| Duration of Disease (years) | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Baseline Crohn's disease activity index (CDAI) Score | CDAI includes abdominal pain, stool frequency, general well-being, presence of complications (arthritis/arthralgia, uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI score is the sum of the 8 weighted scores and approximately ranges from 0 to 600; higher scores indicate more severe disease. | Mean | Standard Deviation | score |
| ||||||||||||||||||
| Number of Prior Exposure to Biologic Therapy | Count of Participants | Participants |
| ||||||||||||||||||||
| Baseline Simple Endoscopic Score for Crohn's Disease (SES-CD) | Assessment of change in Simple Endoscopy Score for Crohn's Disease (SES-CD) from Baseline. Measure Description: The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. | Mean | Standard Deviation | score |
| ||||||||||||||||||
| Concomitant Immunomodulator Use | Count of Participants | Participants |
| ||||||||||||||||||||
| Concomitant Oral Corticosteroid Use | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events | Number of participants who experienced treatment-emergent adverse events (AEs) | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 12 |
|
|
| ||||||||||||||||||||||||||
| Primary | Serious Adverse Events | Number of participants who experienced serious adverse events (SAEs) | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Primary | Adverse Events Leading to Discontinuation | Number of participants who experienced AEs leading to discontinuation | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Primary | Endoscopic Improvement | Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease [SES-CD] ≥ 50% from Baseline) | All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores with no important protocol deviations. | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Clinical Remission | Number of participants achieving clinical remission, as defined by Crohn's disease activity index [CDAI] score < 150 | All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores. | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Endoscopic and Clinical Improvement | Number of participants who achieved a decrease in SES-CD ≥ 50% AND reduction in CDAI ≥ 100 points from Baseline or CDAI<150 | All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores. | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving a Composite Response | Composite response is defined as a decrease by at least 50% in hsCRP or fecal calprotectin from baseline and a reduction of either CDAI ≥ 100 points from Baseline or CDAI<150 in subjects with at least one elevated biomarker at baseline. | All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores with at least one elevated biomarker at Baseline. | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Normalization of C-reactive Protein | Number of participants with normalization of hsCRP (as defined by hsCRP < 5 mg/L), among subjects with elevated concentrations at Baseline, at Week 12 | All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores who have elevated hsCRP values at Baseline. | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Normalization of Fecal Calprotectin | Number of participants with normalization of fecal calprotectin (fecal calprotectin < 250 ug/g), among subjects with elevated concentrations at Baseline, at Week 12 | All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores with elevated fecal calprotectin at Baseline. | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Clinical Response | Clinical response is defined as either a reduction of either CDAI ≥ 100 points from Baseline or CDAI<150. | All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores. | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Two Component Patient-reported Outcome (PRO-2) Remission | Number of subjects with PRO-2 remission (defined as average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than Baseline) at Week 12. | All subjects who have been treated with PRA023 with Baseline CDAI and SES-CD scores. | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD) | Assessment of change in simple endoscopy score for Crohn's Disease (SES-CD) from Baseline. Measure Description: The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. | All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores, who have SES-CD scores at Baseline and Week 12. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Concentration of PRA023 (MK-7240) | Blood samples were obtained for PK analysis of the serum concentration of PRA023 at week 12. | All participants who were treated with PRA023 with Baseline CDAI and SES-CD scores, and had blood samples drawn for serum concentration of PRA023 | Posted | Mean | Standard Deviation | ng/mL | Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants Positive for Anti-drug Antibody (ADA) | Blood samples were collected for the determination of anti-PR023 antibodies based on confirmatory assay. The number of participants with confirmed positive anti-PR023 antibodies results at any visit during the study is presented. | All participants who were treated with PRA023 with Baseline CDAI and SES-CD scores and had blood samples collected for ADA determination | Posted | Count of Participants | Participants | Up to approximately 12 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Neutralizing Anti-Bodies (NAB) | Blood samples were collected for the determination of NAB. The number of participants with positive NAB results at any visit during the study is presented. | All participants who were treated with PRA023 with Baseline CDAI and SES-CD scores and who were ADA positive post-baseline | Posted | Count of Participants | Participants | Up to approximately 12 weeks |
|
|
14 weeks
Adverse event assessment occurred at every scheduled visit. An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRA023 | Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol. | 0 | 55 | 8 | 55 | 20 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's Disease | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Prometheus Biosciences, Inc. | 858-422-4300 | mm@prometheusbiosciences.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 19, 2022 | Sep 11, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 2 Prior Biologics |
|
| >=3 Prior Biologics |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|