A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy

Crohn Disease Clinical Trial

Official title:

A Phase 2/3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05470985
• Other study ID #: IM047-023
• Secondary ID: 2021-005019-30
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 22, 2023
• Est. completion date: March 16, 2032

Study information

• Verified date: June 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 16, 2032
• Est. primary completion date: September 24, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• Participants must have a Pediatric Crohn's Disease Activity Index (PCDAI) score = 30 and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score = 6 (or SES-CD = 4 in participants with isolated ileal disease)
• Participant has an inadequate response, intolerance, or loss of response to at least 1 of the following treatments for Crohn's Disease (CD): i) corticosteroids ii) immunomodulators iii) biologic therapy iv) other systemic immunomodulatory therapies for CD

Exclusion Criteria:

• Participant is likely to require, in the physician's judgment, bowel resection within 12 weeks of entry into the study
• Participant has current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician's judgment, surgical or medical intervention within 12 weeks of entry into the study or need for ileostomy or colostomy
• Participant has extensive small bowel resection (> 100 cm) or known diagnosis of short bowel syndrome or participant requires total parenteral nutrition Other protocol-defined inclusion/exclusion criteria apply.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Ozanimod
Specific dose on specific days

Locations

Country	Name	City	State
Australia	Local Institution - 0051	Clayton	Victoria
Australia	Local Institution - 0045	Joonladup	Western Australia
Australia	Local Institution - 0056	Parkville	Victoria
Australia	Local Institution - 0068	Randwick	New South Wales
Australia	Local Institution - 0036	South Brisbane	Queensland
Australia	Local Institution - 0029	Sydney	New South Wales
Belgium	Queen Fabiola Children's University Hospital	Brussel	BRU
Belgium	Universitair Ziekenhuis Brussel	Brussel
Belgium	Local Institution - 0055	Bruxelles
Belgium	Universitair Ziekenhuis Leuven	Leuven	VBR
Belgium	Groupe sante CHC - Clinique du MontLegia	Liege	WLG
Belgium	Local Institution - 0048	Liège	WLG
Canada	Local Institution - 0014	Halifax	Nova Scotia
Canada	Local Institution - 0001	London	Ontario
Canada	CHU Sainte-Justine	Montreal	Quebec
Canada	Local Institution - 0039	Toronto	Ontario
France	Hôpital Pierre Wertheimer	Bron
France	CHU Caen	Caen
France	Hôpital Necker - Enfants Malades	Paris
France	Hôpital des Enfants - Toulouse	Toulouse
Germany	Local Institution - 0057	Dresden	SN
Germany	Local Institution - 0074	Giessen
Germany	Local Institution - 0067	Leipzig	SN
Germany	Local Institution - 0073	Munchen	BY
Germany	Local Institution - 0077	Wuppertal	Northwest
Hungary	Local Institution - 0015	Miskolc
Hungary	Local Institution - 0019	Miskolc	BZ
Hungary	Szegedi Tudományegyetem	Szeged
Poland	Local Institution - 0041	Krakow	MA
Poland	Local Institution - 0061	Lodz
Poland	Local Institution - 0052	Rzeszow	PK
Poland	Local Institution - 0082	Szczecin
Poland	"Instytut ""Pomnik - Centrum Zdrowia Dziecka"""	Warsaw
Poland	Local Institution - 0031	Warszawa
Poland	WIP Warsaw IBD Point	Warszawa	MZ
Spain	Local Institution - 0030	Badalona
Spain	Local Institution - 0025	Barcelona	B
Spain	Local Institution - 0035	Barcelone
Spain	Local Institution - 0013	Madrid
Spain	Local Institution - 0017	Madrid
Spain	Local Institution - 0021	Madrid
United Kingdom	Local Institution - 0046	Birmingham	BIR
United Kingdom	Local Institution - 0049	London
United Kingdom	Local Institution - 0050	London	LND
United Kingdom	Local Institution - 0069	Sheffield	SHF
United States	Emory-Children's Center	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Johns Hopkins Children's Center - Pediatric Inflammatory Bowel Disease (IBD) Center	Baltimore	Maryland
United States	Local Institution - 0032	Boston	Massachusetts
United States	The Children's Hospital at Montefiore	Bronx	New York
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Cook Children's Gastroenterology	Fort Worth	Texas
United States	Local Institution - 0010	Garden Grove	California
United States	Local Institution - 0011	Hartford	Connecticut
United States	Local Institution - 0080	Hershey	Pennsylvania
United States	Texas Children's Hospital	Houston	Texas
United States	Riley Hospital For Children	Indianapolis	Indiana
United States	University of Iowa Stead Family Children's Hospital	Iowa City	Iowa
United States	Local Institution - 0083	Kissimmee	Florida
United States	Dartmouth-Hitchcock Medical Center (DHMC) - Children's Hospital at Dartmouth (CHaD) - Lebanon	Lebanon	New Hampshire
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Local Institution - 0076	Los Angeles	California
United States	Local Institution - 0081	Madison	Wisconsin
United States	Morristown Medical Center	Morristown	New Jersey
United States	Local Institution - 0078	Neenah	Wisconsin
United States	Icahn School of Medicine - The Mount Sinai Hospital - The Susan and Leonard Feinstein IBD Center	New York	New York
United States	Morgan Stanley Children's Hospital of NewYork-Presbyterian	New York	New York
United States	Local Institution - 0079	Oklahoma City	Oklahoma
United States	Measurable Outcomes Research	Oklahoma City	Oklahoma
United States	AdventHealth (Florida Hospital) Medical Group - Pediatric Gastroenterology - Orlando	Orlando	Florida
United States	Arnold Palmer Hospital for Children - Center for Digestive Health and Nutrition - Downtown Orlando	Orlando	Florida
United States	Local Institution - 0043	Paramus	New Jersey
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Mayo Clinic - Children's Center - Rochester	Rochester	Minnesota
United States	University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)	Rochester	New York
United States	UC Davis Medical Center - UC Davis Medical Group - Pediatric Specialty Clinics	Sacramento	California
United States	Washington University School of Medicine in St. Louis - St. Louis Children's Hospital	Saint Louis	Missouri
United States	UCSF Medical Center- Mission Bay	San Francisco	California
United States	Seattle Children's Hospital, Research and Foundation	Seattle	Washington
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Mary Bridge Children's Outpatient Center - Tacoma	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Hungary,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10		At week 64
Primary	Proportion of participants achieving Simple Endoscopic Score for Crohn's Disease (SES-CD) = 2 or SES-CD = 4 points with no SES-CD subscore > 1 point		At week 64
Secondary	Proportion of participants who achieve PCDAI < 10		At week 12
Secondary	Proportion of participants who achieve SES-CD decrease from Baseline of = 50% (ER-50)		At week 12 and week 64
Secondary	Proportion of participants who achieve reduction in PCDAI score = 12.5		At week 12 and week 64
Secondary	Proportion of participants who achieve total PCDAI score of < 30 points		At week 12 and week 64
Secondary	Proportion of adolescents who achieve an average daily abdominal pain score = 1 point		At week 12 and week 64
Secondary	Proportion of adolescents who achieve an average daily stool frequency = 3 points with abdominal pain		At week 12 and week 64
Secondary	Proportion of adolescents who achieve stool frequency no worse than Baseline		At week 12 and week 64
Secondary	Change from Baseline in stool frequency score over time		Up to 81 weeks
Secondary	Change from baseline in abdominal pain over time measured by Pediatric Crohn's Disease Activity Index (graded from 0-10)		Up to 81 weeks
Secondary	Proportion of adolescents who achieve Crohn's Disease Activity Index (CDAI) score < 150		At week 12 and week 64
Secondary	Proportion of adolescents who achieve CDAI reduction from Baseline of = 100 points or CDAI score < 150		At week 12 and week 64
Secondary	Proportion of participants who achieve a PCDAI score < 10 while remaining corticosteroid free in the prior 12 weeks		At week 64
Secondary	Proportion of participants who achieve a CDAI score < 150 while remaining corticosteroid free in the prior 12 weeks (adolescents only)		At week 64
Secondary	Proportion of participants achieving SES-CD = 2 or SES-CD = 4 points with no SES-CD subscore > 1 point		At week 12
Secondary	Steady state systemic exposures of ozanimod		At week 20 and up to 81 weeks
Secondary	Steady state systemic exposures of CC112273		At week 20 and up to 81 weeks
Secondary	Absolute change from Baseline in absolute lymphocyte count (ALC)		At week 12, week 64, and up to 81 weeks
Secondary	Percent change from Baseline in ALC		At week 12, week 64, and up to 81 weeks
Secondary	Number of participants with Adverse Events (AEs)		Up to 81 weeks
Secondary	Number of participants with Serious Adverse Events (SAEs)		Up to 81 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting