NCT05013905|CompletedPhase 2ResultsDMCFDA DrugFDA Device

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)

APOLLO-CD

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

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

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5 other identifiers

PR200-1037240-0062023-509742-35-00U1111-1309-61082021-000092-37

Study Type

interventional

Target

Locations

8 countries

Sites

Timeline

RegisteredAug 2021

StartedJul 2021

CompletionMay 2025

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jul 2021

Typical duration for phase_2

Geographic Reach

8 countries

37 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

Study Start

First participant enrolled

July 28, 2021

Completed

16 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2021

Completed

6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2022

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

November 1, 2023

Completed

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2025

Completed

Last Updated

April 21, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

August 13, 2021

Results QC Date

September 11, 2023

Last Update Submit

March 31, 2026

Conditions

Crohn Disease

Keywords

APOLLO-CDAPOLLOCrohn's Disease

Outcome Measures

Primary Outcomes (4)

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

Secondary Outcomes (11)

Clinical Remission
Week 12
Endoscopic and Clinical Improvement
Week 12
Number of Participants Achieving a Composite Response
Week 12
Normalization of C-reactive Protein
Week 12
Normalization of Fecal Calprotectin
Week 12
+6 more secondary outcomes

Study Arms (3)

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.

Biological: TulisokibartDiagnostic Test: Companion Diagnostic (CDx)

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).

Biological: Tulisokibart

OLE Tulisokibart 250 mg

EXPERIMENTAL

Biological: Tulisokibart

Interventions

Companion Diagnostic (CDx)DIAGNOSTIC_TEST

PRA023 CDx Genotyping Assay

Induction Tulisokibart

TulisokibartBIOLOGICAL

Tulisokibart administered by IV infusion as directed by the protocol

Also known as: PRA023, MK-7240

Induction TulisokibartOLE Tulisokibart 100 mgOLE Tulisokibart 250 mg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.