Clinical trial NCT03440372: Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Official title: Induction Study #1 - 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: TERMINATED
Phase: PHASE3
Conditions: Crohn Disease
Keywords: Crohn's Disease
Crohn Disease
Oral
Ozanimod
Moderately active
Severely active
RPC01
RPC01-3201
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 625
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: 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 therapies
* Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
* An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
* Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria:

* Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
* Has 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: Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of participants with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline
timeFrame: Week 12
measure: Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50%
timeFrame: Week 12
measure: Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150
timeFrame: Week 12
measure: Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50%
timeFrame: Week 12
measure: Proportion of participants with CDAI score < 150 and SES-CD decrease from baseline of ≥ 50%
timeFrame: Week 12
measure: Proportion of participants with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD ≤ 4 points and decrease ≥2 points
timeFrame: Week 12
measure: Proportion of participants with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD decrease from baseline of ≥ 50%
timeFrame: Week 12
measure: Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes)
timeFrame: Week 12
measure: Proportion of participants with CDAI reduction from baseline of ≥ 70 points
timeFrame: Week 12
measure: Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10%
timeFrame: Week 12
measure: Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50%
timeFrame: Week 12
Other outcomes:
Locations:
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country: United States
facility: Holland Center for Family Health
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city: Lodz
country: Poland
facility: Local Institution - 829
city: Lodz
country: Poland
facility: Local Institution - 888
city: Lublin
country: Poland
facility: Local Institution - 760
city: Olsztyn
country: Poland
facility: Local Institution - 830
city: Opole
country: Poland
facility: Local Institution - 402
city: Oswiecim
country: Poland
facility: Local Institution - 400
city: Poznan
country: Poland
facility: Local Institution - 758
city: Poznan
country: Poland
facility: Local Institution - 575
city: Poznan
country: Poland
facility: Local Institution - 401
city: Sopot
country: Poland
facility: Local Institution - 239
city: Szczecin
country: Poland
facility: Local Institution - 235
city: Torun
country: Poland
facility: Local Institution - 822
city: Tychy
country: Poland
facility: Local Institution - 824
city: Ul. Piotrkowska 177
country: Poland
facility: Local Institution - 827
city: Warsaw
country: Poland
facility: Local Institution - 410
city: Warsaw
country: Poland
facility: Local Institution - 236
city: Warszawa
country: Poland
facility: Local Institution - 576
city: Warszawa
country: Poland
facility: Local Institution - 825
city: Bucharest
country: Romania
facility: Local Institution - 808
city: Bucharest
country: Romania
facility: Local Institution - 836
city: Bucharest
country: Romania
facility: Local Institution - 499
city: Bucharest
country: Romania
facility: Local Institution - 795
city: Bucharest
country: Romania
facility: Local Institution - 837
city: Bucharest
country: Romania
facility: Local Institution - 839
city: Bucharest
country: Romania
facility: Local Institution - 842
city: Craiova
country: Romania
facility: Local Institution - 843
city: Napoca
country: Romania
facility: Local Institution - 838
city: Targu Mures
country: Romania
facility: Local Institution - 840
city: Chita
country: Russian Federation
facility: Local Institution - 598
city: Irkutsk
country: Russian Federation
facility: Local Institution - 848
city: Kazan
country: Russian Federation
facility: Local Institution - 892
city: Khanty-mansiysk
country: Russian Federation
facility: Local Institution - 599
city: Krasnoyarsk
country: Russian Federation
facility: Local Institution - 927
city: Moscow
country: Russian Federation
facility: Local Institution - 851
city: Novosibirsk
country: Russian Federation
facility: Local Institution - 594
city: Petrozavodsk
country: Russian Federation
facility: Local Institution - 858
city: Pushkin
country: Russian Federation
facility: Local Institution - 859
city: Pyatigorsk
country: Russian Federation
facility: Local Institution - 960
city: Pyatigorsk
country: Russian Federation
facility: Local Institution - 846
city: Rostov-on-Don
country: Russian Federation
facility: Local Institution - 883
city: Saint Petersburg
country: Russian Federation
facility: Local Institution - 847
city: Samara
country: Russian Federation
facility: Local Institution - 844
city: St Petersburg
country: Russian Federation
facility: Local Institution - 862
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 857
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 845
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 856
city: Tula
country: Russian Federation
facility: Local Institution - 806
city: Ufa
country: Russian Federation
facility: Local Institution - 861
city: Veliky Novgorod
country: Russian Federation
facility: Local Institution - 855
city: Vladimir
country: Russian Federation
facility: Local Institution - 935
city: Vladivostok
country: Russian Federation
facility: Local Institution - 999
city: Vladivostok
country: Russian Federation
facility: Local Institution - 986
city: Dammam
country: Saudi Arabia
facility: Local Institution - 534
city: Jeddah
country: Saudi Arabia
facility: Local Institution - 537
city: Riyadh
country: Saudi Arabia
facility: Local Institution - 536
city: Riyadh
country: Saudi Arabia
facility: Local Institution - 535
city: Belgrade
country: Serbia
facility: Local Institution - 241
city: Belgrade
country: Serbia
facility: Local Institution - 245
city: Belgrade
country: Serbia
facility: Local Institution - 246
city: Alicante
country: Spain
facility: Local Institution - 703
city: Badalona
country: Spain
facility: Local Institution - 690
city: La Laguna
country: Spain
facility: Local Institution - 698
city: Madrid
country: Spain
facility: Local Institution - 691
city: Madrid
country: Spain
facility: Local Institution - 692
city: Sevilla
country: Spain
facility: Local Institution - 696
city: Sevilla
country: Spain
facility: Local Institution - 705
city: Viladecans
country: Spain
facility: Local Institution - 700
city: Bern
country: Switzerland
facility: Local Institution - 967
city: St.Gallen
country: Switzerland
facility: Local Institution - 968
city: Zurich
country: Switzerland
facility: Local Institution - 969
city: Kozlu
country: Taiwan
facility: Local Institution - 363
city: Ankara
country: Turkey
facility: Local Institution - 356
city: Bursa
country: Turkey
facility: Local Institution - 360
city: Istanbul
country: Turkey
facility: Local Institution - 362
city: Istanbul
country: Turkey
facility: Local Institution - 355
city: Izmit/Kocaeli
country: Turkey
facility: Local Institution - 354
city: Trabzon
country: Turkey
facility: Local Institution - 359
city: Chernivtsi
country: Ukraine
facility: Local Institution - 914
city: Dnipropetrovsk
country: Ukraine
facility: Local Institution - 950
city: Ivano-Frankivsk
country: Ukraine
facility: Local Institution - 229
city: Ivano-Frankivsk
country: Ukraine
facility: Local Institution - 912
city: Kharkiv
country: Ukraine
facility: Local Institution - 919
city: Kyiv
country: Ukraine
facility: Local Institution - 901
city: Kyiv
country: Ukraine
facility: Local Institution - 915
city: Kyiv
country: Ukraine
facility: Local Institution - 243
city: Kyiv
country: Ukraine
facility: Local Institution - 911
city: Kyiv
country: Ukraine
facility: Local Institution - 244
city: Kyiv
country: Ukraine
facility: Local Institution - 918
city: Kyiv
country: Ukraine
facility: Local Institution - 908
city: Kyiv
country: Ukraine
facility: Local Institution - 562
city: Lutsk
country: Ukraine
facility: Local Institution - 240
city: Lviv
country: Ukraine
facility: Local Institution - 234
city: Lviv
country: Ukraine
facility: Local Institution - 910
city: Odesa
country: Ukraine
facility: Local Institution - 242
city: Poltava
country: Ukraine
facility: Local Institution - 905
city: Ternopil
country: Ukraine
facility: Local Institution - 934
city: Vinnytsia
country: Ukraine
facility: Local Institution - 909
city: Vinnytsia
country: Ukraine
facility: Local Institution - 224
city: Vinnytsia
country: Ukraine
facility: Local Institution - 971
city: Southampton
country: United Kingdom
facility: Local Institution - 723
state: Hampshire
city: London
country: United Kingdom
facility: Local Institution - 729
state: LND
city: Birmingham
country: United Kingdom
facility: Local Institution - 557
city: Bristol
country: United Kingdom
facility: Local Institution - 714
city: Cardiff
country: United Kingdom
facility: Local Institution - 560
city: Chorley
country: United Kingdom
facility: Local Institution - 558
city: Corbridge Road
country: United Kingdom
facility: Local Institution - 559
city: Dundonald
country: United Kingdom
facility: Local Institution - 712
city: Glasgow
country: United Kingdom
facility: Local Institution - 713
city: Lancashire Blackpool
country: United Kingdom
facility: Local Institution - 716
city: London
country: United Kingdom
facility: Local Institution - 722
city: London
country: United Kingdom
facility: Local Institution - 715
city: North Manchester Science Park
country: United Kingdom
facility: Local Institution - 561
city: Shrewsbury
country: United Kingdom
facility: Local Institution - 593
city: Torquay
country: United Kingdom
facility: Local Institution - 718
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.