Clinical trial NCT02531113: Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease
Official title: A Phase 2, Multi-Center, Open-Label Induction Trial With Extension Period to Access Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients With Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2015-08-24
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.

Detailed description: This open-label trial is composed of two periods: Induction and Extension. All eligible patients will be enrolled into the 12-Week Induction period and receive study medication. Patients who complete the Induction period may then be eligible to enter the 100-Week Extension period where they will continue to receive study medication.

Eligibility criteria: Key Inclusion Criteria:

* Crohn's disease (CD) confirmed by endoscopy and histology
* Active disease as evaluated by Crohn's Disease Activity Index Score and Simple Endoscopic Score for CD
* Inadequate response to aminosalicylates, corticosteroids, immunomodulators or biologic therapy

Key Exclusion Criteria:

* Diagnosis of ulcerative colitis or indeterminate colitis
* Known strictures/stenosis leading to symptoms of obstruction
* Current stoma or need for ileostomy or colostomy
* Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
* History of uveitis or known macular edema
* History of colonic dysplasia

Primary outcomes:
measure: Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) (Paired Segments) From Baseline at Week 12 as Determined by a Blinded Central Reader.
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period
timeFrame: From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Other outcomes:
measure: Change in the Crohn's Disease Activity Index (CDAI) Score From Baseline at Week 12
timeFrame: Baseline to Week 12
measure: Percentage of Participants With Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved a Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved Clinical Remission Based on Patient-Reported Outcome (PRO2) Measure Definitions at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved a Clinical Response Based on Patient Reported Outcome (PRO2) Measures From Baseline at Week 12
timeFrame: Week 12
measure: Percentage of Participants of Participants Who Achieved Endoscopic Remission Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Definitions at Week 12 (Paired Segments)
timeFrame: Week 12
measure: Percentage of Participants Who Achieved an Endoscopic Response-50 (Paired Segment) Based on Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Definitions at Week 12
timeFrame: Week 12
measure: Change in Roberts Intestinal Histopathology Index From Baseline (Paired Segments) at Week 12
timeFrame: Week 12
measure: Improvement in Perianal and Enterocutaneous Fistulas
timeFrame: Week 12
measure: Percentage of Participants Who Achieved Endoscopic Remission Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Definitions at Week 52 - Observed Cases
timeFrame: Week 52
measure: Percentage of Participants Who Achieved an Endoscopic Response-50 Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Definitions at Week 52
timeFrame: Week 52
measure: Percentage of Participants Who Achieved Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 52
timeFrame: Week 52
measure: Percentage of Participants Who Achieved a Clinical Response Based on CDAI at Week 52
timeFrame: Week 52
measure: Percentage of Participants Who Achieved Clinical Remission Based on Patient-Reported Outcome (PRO2) Measure Definitions at Week 52
timeFrame: Week 52
measure: Percentage of Participants Who Achieved a Clinical Response Based on Patient Reported Outcome (PRO2) Measures From Baseline at Week 52
timeFrame: Week 52
measure: Percentage of Participants in Clinical Remission Based on CDAI and PRO2 Definitions Who Were Off Corticosteroids at Week 52 of Those on Corticosteroids
timeFrame: Week 52
measure: Percentage of Participants With Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Weeks 4 and 8
timeFrame: Weeks 4 and 8
measure: Percentage of Participants Who Achieved a Clinical Response Based on CDAI at Weeks 4 and 8
timeFrame: Weeks 4 and 8
measure: Percentage of Participants Who Achieved Clinical Remission Based on Patient-Reported Outcome (PRO2) Measure Definitions at Weeks 4 and 8
timeFrame: Weeks 4 and 8
measure: Percentage of Participants Who Achieved a Clinical Response Based on Patient Reported Outcome (PRO2) Measures at Weeks 4 and 8
timeFrame: Weeks 4 and Week 8
measure: Percentage of Participants With RHI Healing at Week 52
timeFrame: Week 52
measure: Change in Fecal Calprotectin (Observed Cases) at Weeks 12 and 52
timeFrame: Baseline to Weeks 12 and Week 52
measure: Change in Serum C-Reactive Protein (CRP) Levels From Baseline (Observed Cases) at Weeks 12 and 52
timeFrame: Baseline to Weeks 12 and 52
measure: Changes in Biomarkers: Percentage of Participants With CRP Response-10 - Non-responder Imputation
timeFrame: Week 12, Week 52
measure: Changes in Biomarkers: Percentage of Participants With FCP Response-250 - Non-responder Imputation
timeFrame: Week 12, Week 52
measure: Improvement in Perianal and Enterocutaneous Fistulas in Participants With Fistula's From Baseline at Weeks 4 and 8
timeFrame: Baseline to Week 4 and 8
measure: Pharmacokinetic Plasma Concentration of Ozanimod
timeFrame: From Day 1 to Week 52
measure: PK Plasma Concentration of Active Metabolite CC-112273
timeFrame: From Day 1 to Week 52
measure: Change From Baseline in Absolute Lymphocyte Count (ALC) Derived From Hematology Laboratory Results at Weeks 4, 8 and 12
timeFrame: Baseline up to Weeks 4, 8 and 12
Locations:
city: Tucson
country: United States
facility: Adobe Clinical Research LLC
state: Arizona
city: Largo
country: United States
facility: Florida Center for Gastroenterology
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC, Inc.
state: Florida
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialists PC
state: Georgia
city: Oak Lawn
country: United States
facility: DM Clinical Research
state: Illinois
city: Baton Rouge
country: United States
facility: Gastroenterology Associates LLC
state: Louisiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Belton
country: United States
facility: Ehrhardt Clinical Research LLC
state: Missouri
city: Cincinnati
country: United States
facility: UC Health Clinical Trials Office
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Clinical Trials Management Office
state: Ohio
city: Orangeburg
country: United States
facility: Gastroenterology Associates of Orangeburg
state: South Carolina
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: San Antonio
country: United States
facility: San Antonio Gastroenterology
state: Texas
city: London
country: Canada
facility: LHSC Victoria Hospital
state: Ontario
city: Budapest
country: Hungary
facility: Szent Margit Korhaz
city: Szekszárd
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz
city: Lodz
country: Poland
facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia
city: Lublin
country: Poland
facility: GASTROMED Sp.zo.o.
city: Warsaw
country: Poland
facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy
city: Warsaw
country: Poland
facility: Centralny Szpital Kliniczny MSWIA
city: Warsaw
country: Poland
facility: Nzoz Vivamed
city: Dnipropetrovsk
country: Ukraine
facility: Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases
city: Kharkiv
country: Ukraine
facility: Kharkiv City Clinical Hospital 2
city: Kyiv
country: Ukraine
facility: Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
city: Kyiv
country: Ukraine
facility: Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical
city: Zaporizhia
country: Ukraine
facility: CI City Hospital #1
Study officials:
affiliation: Celgene Corporation
name: Kanthi Kollengode, MD
role: STUDY_DIRECTOR
References:
citation: Feagan BG, Sandborn WJ, Danese S, Wolf DC, Liu WJ, Hua SY, Minton N, Olson A, D'Haens G. Ozanimod induction therapy for patients with moderate to severe Crohn's disease: a single-arm, phase 2, prospective observer-blinded endpoint study. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):819-828. doi: 10.1016/S2468-1253(20)30188-6. Epub 2020 Jun 15.