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Completed

NCT Number: NCT05013905

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)

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prometheus Biosciences Selected Site, Bankstown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of Crohn's disease (CD)
  • Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy
  • Must have corticosteroid dependence or have had no response, insufficient response, loss of response and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF), anti-integrin, or anti-interleukin (IL)12/23
  • Able to provide written informed consent and understand and comply with the requirements of the study

Exclusion criteria

  • Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug
  • Diagnosis of ulcerative colitis (UC) or indeterminate colitis
  • CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or illeal involvement
  • Suspected or diagnosed intra-abdominal or perianal abscess at screening
  • Current stoma or need for colostomy or ileostomy
  • Previous small bowel resection with a combined resected length of >100 cm or previous colonic resection of > 2 segments
  • Surgical bowel resection within 3 months before screening
  • Past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed
  • Participants in the opinion of the investigator are at an unacceptable risk for participation in the study
  • Participants who meet the protocol criteria for important laboratory exclusion criteria

Treatment and study plan

Tulisokibart

Biological

Tulisokibart administered by IV infusion as directed by the protocol

Other names: PRA023, MK-7240

Companion Diagnostic (CDx)

Diagnostic Test

PRA023 CDx Genotyping Assay

Primary outcomes

  1. Adverse Events

    Time frame: Up to approximately 18 weeks

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

  2. Serious Adverse Events

    Time frame: Up to approximately 18 weeks

    Number of participants who experienced serious adverse events (SAEs)

  3. Adverse Events Leading to Discontinuation

    Time frame: Up to approximately 12 weeks

    Number of participants who experienced AEs leading to discontinuation

  4. Endoscopic Improvement

    Time frame: Week 12

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

Secondary outcomes

  1. Clinical Remission

    Time frame: Week 12

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

  2. Endoscopic and Clinical Improvement

    Time frame: Week 12

    Number of participants who achieved a decrease in SES-CD ≥ 50% AND reduction in CDAI ≥ 100 points from Baseline or CDAI<150

  3. Number of Participants Achieving Biomarker and Clinical Composite Improvement

    Time frame: Week 12

    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.

  4. Normalization of C-reactive Protein

    Time frame: Week 12

    Number of participants with normalization of hsCRP (as defined by hsCRP < 5 mg/L), among subjects with elevated concentrations at Baseline, at Week 12

  5. Normalization of Fecal Calprotectin

    Time frame: Week 12

    Number of participants with normalization of fecal calprotectin (fecal calprotectin < 250 ug/g), among subjects with elevated concentrations at Baseline, at Week 12

  6. Clinical Response

    Time frame: Week 12

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

  7. Two Component Patient-reported Outcome (PRO-2) Remission

    Time frame: Week 12

    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.

  8. Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)

    Time frame: Baseline and Week 12

    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.

  9. Serum Concentration of Tulisokibart

    Time frame: Week 12

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

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

    Time frame: Up to approximately 12 weeks

    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.

  11. Number of Participants With Positive Neutralizing Anti-Bodies (NAB)

    Time frame: Up to approximately 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry

Registry information

Official study title

A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease

Acronym: APOLLO-CD

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
Aug 19, 2021
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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