Clinical trial NCT03440385: Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Official title: Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn Disease
Keywords: Crohn's Disease
Crohn Disease
Oral
Ozanimod
Moderately active
Severely active
RPC01
RPC01-3202
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 606
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

* Crohn's disease for ≥ 3 months on endoscopy and on histological exam
* Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy
* Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
* Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
* Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria:

* Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
* Extensive small bowel resection (\>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
* Current stoma, ileal-anal pouch anastomosis, or fistula

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission
timeFrame: Week 12
measure: Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%
timeFrame: Week 12
measure: Percentage of Participants With Reduction From Baseline in the Crohn's Disease Activity Index (CDAI) Score of >= 100 Points or a Total CDAI Score < 150
timeFrame: Week 12
measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and SES-CD Decrease From Baseline of ≥ 50%
timeFrame: Week 12
measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%
timeFrame: Week 12
measure: Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission and a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score <= 4 Points and Decrease >= 2 Points
timeFrame: Week 12
measure: Percentage of Participants With Global Histologic Activity Score (GHAS) Remission
timeFrame: Week 12
measure: Percentage of Participants With CDAI Reduction From Baseline of >=70 Points
timeFrame: Week 12
measure: Percentage of Participants With Absence of Ulcers ≥ 0.5 cm With no Segment With Any Ulcerated Surface ≥10%
timeFrame: Week 12
measure: Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50%
timeFrame: Week 12
measure: Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission and an Endoscopic (50%) Response
timeFrame: Week 12
measure: Percentage of Participants With Robarts Histologic Index (RHI) Mucosal Healing at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
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country: United States
facility: Local Institution - 202
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city: La Jolla
country: United States
facility: Ucsd Medical Center
state: California
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facility: Southern California Research Institute Medical Group, Inc.
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city: Tomsk
country: Russian Federation
facility: Local Institution - 877
city: Ufa
country: Russian Federation
facility: Local Institution - 881
city: Volgograd
country: Russian Federation
facility: Local Institution - 880
city: Cape Town
country: Senegal
facility: Local Institution - 546
city: Belgrade
country: Serbia
facility: Local Institution - 887
city: Belgrade
country: Serbia
facility: Local Institution - 596
city: Belgrade
country: Serbia
facility: Local Institution - 886
city: Belgrade
country: Serbia
facility: Local Institution - 890
city: Kragujevac
country: Serbia
facility: Local Institution - 891
city: Novi Sad
country: Serbia
facility: Local Institution - 884
city: Pancevo
country: Serbia
facility: Local Institution - 885
city: Vrsac
country: Serbia
facility: Local Institution - 585
city: Zrenjanin
country: Serbia
facility: Local Institution - 889
city: Bratislava
country: Slovakia
facility: Local Institution - 900
city: Bratislava
country: Slovakia
facility: Local Institution - 894
city: Brezno
country: Slovakia
facility: Local Institution - 895
city: Nitra
country: Slovakia
facility: Local Institution - 899
city: Nove Zamky
country: Slovakia
facility: Local Institution - 897
city: Presov
country: Slovakia
facility: Local Institution - 898
city: Rimavska Sobota
country: Slovakia
facility: Local Institution - 896
city: Celje
country: Slovenia
facility: Local Institution - 904
city: Gauteng
country: South Africa
facility: Local Institution - 543
city: Kempton Park
country: South Africa
facility: Local Institution - 545
city: Pretoria
country: South Africa
facility: Local Institution - 544
city: Pretoria
country: South Africa
facility: Local Institution - 542
city: Pretoria
country: South Africa
facility: Local Institution - 549
city: Somerset West
country: South Africa
facility: Local Institution - 548
city: Val De Grace
country: South Africa
facility: Local Institution - 547
city: Barcelona
country: Spain
facility: Teknon Medical Center
city: Cordoba
country: Spain
facility: University Hospital Reina Sofia
city: Girona
country: Spain
facility: University Hospital of Girona Dr. Josep Trueta
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario De Gran Canaria Dr. Negrin
city: Madrid
country: Spain
facility: Local Institution - 695
city: Majadahonda, Madrid
country: Spain
facility: University Hospital Puerta de Hierro Majadajonda
city: Santander
country: Spain
facility: University Hospital Marques de Valdecilla (HUMV)
city: Valencia
country: Spain
facility: Local Institution - 697
city: Stockholm
country: Sweden
facility: Local Institution - 625
city: Kaohsiung, San Ming Dist.
country: Taiwan
facility: Local Institution - 463
city: Kaohsiung
country: Taiwan
facility: Local Institution - 460
city: Niao-Sung Hsiang Kaohsiung County
country: Taiwan
facility: Local Institution - 461
city: Tainan, Taiana
country: Taiwan
facility: Local Institution - 459
city: Taoyuan City
country: Taiwan
facility: Local Institution - 462
city: Tapei, Beitou Dist.
country: Taiwan
facility: Local Institution - 464
city: Tapei
country: Taiwan
facility: Local Institution - 465
city: Ankara
country: Turkey
facility: Local Institution - 357
city: Elazig
country: Turkey
facility: Local Institution - 365
city: Istanbul
country: Turkey
facility: Local Institution - 358
city: Istanbul
country: Turkey
facility: Local Institution - 361
city: Kadiköy/Istanbul
country: Turkey
facility: Local Institution - 353
city: Chernivtsi
country: Ukraine
facility: Local Institution - 922
city: Ivano-Frankivsk
country: Ukraine
facility: Local Institution - 929
city: Kharkiv
country: Ukraine
facility: Local Institution - 965
city: Khmelnytskyi
country: Ukraine
facility: Local Institution - 920
city: Kropyvnytskyi
country: Ukraine
facility: Local Institution - 933
city: Kyiv
country: Ukraine
facility: Local Institution - 923
city: Kyiv
country: Ukraine
facility: Local Institution - 563
city: Kyiv
country: Ukraine
facility: Local Institution - 564
city: Kyiv
country: Ukraine
facility: Local Institution - 977
city: Lutsk
country: Ukraine
facility: Local Institution - 590
city: Lviv
country: Ukraine
facility: Local Institution - 974
city: Odesa
country: Ukraine
facility: Local Institution - 902
city: Vinnytsia
country: Ukraine
facility: Local Institution - 924
city: Vinnytsya
country: Ukraine
facility: Local Institution - 932
city: Zaporizhia
country: Ukraine
facility: Local Institution - 587
city: Zaporizhzhya
country: Ukraine
facility: Local Institution - 925
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5.