A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006)

Clinical Remission

Number of participants achieving clinical remission, as defined by Crohn's disease activity index \[CDAI\] score \< 150

Time frame: 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

Time frame: Week 12

Number of Participants Achieving Biomarker and Clinical Composite Improvement

Biomarker and clinical composite improvement 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.

Time frame: 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

Time frame: 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

Time frame: Week 12

Clinical Response

Clinical response is defined as either a reduction of either CDAI ≥ 100 points from Baseline or CDAI\<150.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and Week 12

Serum Concentration of Tulisokibart

Blood samples were obtained for PK analysis of the serum concentration of tulisokibart at week 12.

Time frame: Week 12

Number of Participants Positive for Anti-drug Antibody (ADA)

Blood samples were collected for the determination of anti-tulisokibart antibodies based on confirmatory assay. The number of participants with confirmed positive anti-tulisokibart antibodies results at any visit during the study is presented.

Time frame: 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.

Time frame: Up to approximately 12 weeks