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Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease

Primary Purpose

Crohn's Disease

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

RPC1063

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Adobe Clinical Research LLC
Florida Center for Gastroenterology
IMIC, Inc.
Atlanta Gastroenterology Specialists PC
DM Clinical Research
Gastroenterology Associates LLC
Chevy Chase Clinical Research
Ehrhardt Clinical Research LLC
UC Health Clinical Trials Office
Ohio State University Clinical Trials Management Office
Gastroenterology Associates of Orangeburg
Gastro One
San Antonio Gastroenterology
LHSC Victoria Hospital
Szent Margit Korhaz
Tolna Megyei Balassa Janos Korhaz
Santa Familia Centrum Badan, Profilaktyki i Leczenia
GASTROMED Sp.zo.o.
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Centralny Szpital Kliniczny MSWIA
Nzoz Vivamed
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases
Kharkiv City Clinical Hospital 2
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
Lviv Regional Clinical Hospital
Vinnytsia Regional Clinical
CI City Hospital #1

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RPC1063 (Ozanimod)

Arm Description

Outcomes

Primary Outcome Measures

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.

The simple endoscopy score (SES-CD) assesses the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components are scored on a scale of 0 to 3. In the SES-CD, each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right, transverse, left (descending and sigmoid), and rectum. The SES-CD is the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores is 0 - 12 for each segment, and 0 - 56 for the overall SES-CD score, with larger scores indicating greater severity of disease.

Secondary Outcome Measures

The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period

A TEAE = any event with an onset date on or after the first dose date, or any ongoing event on the first dose date that worsens in severity or after the first dose date and until 90 days following the last dose of study drug treatment. An AE = untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which that does not necessarily have a causal relationship with the investigational treatment. An AE can be any unfavorable or unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not considered related to the investigational medicinal product. A serious AE (experience) or reaction is any untoward medical occurrence that at any dose Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity, or Is a congenital abnormality/birth defect

Full Information

NCT ID

NCT02531113

First Posted

August 20, 2015

Last Updated

January 4, 2021

Sponsor

Celgene

1. Study Identification

Unique Protocol Identification Number

NCT02531113

Brief Title

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

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

October 9, 2015 (Actual)

Primary Completion Date

September 12, 2019 (Actual)

Study Completion Date

November 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celgene

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RPC1063 (Ozanimod)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

RPC1063

Other Intervention Name(s)

Ozanimod

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

Baseline to Week 12

Secondary Outcome Measure Information:

Title

The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period

Description

Time Frame

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 Pre-specified Outcome Measures:

Title

Change in the Crohn's Disease Activity Index (CDAI) Score From Baseline at Week 12

Description

The Crohn's Disease Activity Index is a composite score that is used to measure the clinical activity of Crohn's disease. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. Baseline was defined as the last non-missing record on or before the first dose of study drug.

Time Frame

Baseline to Week 12

Title

Percentage of Participants With Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12

Description

Clinical Remission is defined as a CDAI score of < 150. The Crohn's Disease Activity Index is a composite score that is used to measure the clinical activity of Crohn's disease. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Time Frame

Week 12

Title

Percentage of Participants Who Achieved a Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Week 12

Description

Clinical Response is defined as a CDAI reduction from baseline of ≥ 100 points. The Crohn's Disease Activity Index is a composite score that is used to measure the clinical activity of Crohn's disease. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Time Frame

Week 12

Title

Percentage of Participants Who Achieved Clinical Remission Based on Patient-Reported Outcome (PRO2) Measure Definitions at Week 12

Description

The PRO2 is a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency (SF) and abdominal pain (AP) (rated on a scale of 0-3) assessed for 7 days. Clinical Remission (SF and AP remission) was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Time Frame

Week 12

Title

Percentage of Participants Who Achieved a Clinical Response Based on Patient Reported Outcome (PRO2) Measures From Baseline at Week 12

Description

Clinical response based on PRO2 was defined as PRO2 decrease of ≥50% from baseline. The PRO2 is a composite score based on 2 components of the Crohn's Disease Activity Index, the number of liquid or soft stools/day for 7 days and the abdominal pain (rated on a scale of 0-3) assessed for 7 days. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Time Frame

Week 12

Title

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)

Description

Endoscopic remission is defined as SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points with no SES-CD sub-score >1point. The SES-CD assesses the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components are scored on a scale of 0 to 3. In the SES-CD, each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right, transverse, left (descending and sigmoid), and rectum. The SES-CD is the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores is 0 - 12 for each segment, and 0 - 56 for the overall SES-CD score, with larger scores indicating greater severity of disease. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Time Frame

Week 12

Title

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

Description

Endoscopic Response is defined as a SES-CD decrease from baseline of ≥ 50%. The SES-CD assesses the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components are scored on a scale of 0 to 3. In the SES-CD, each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right, transverse, left (descending and sigmoid), and rectum. The SES-CD is the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores is 0 - 12 for each segment, and 0 - 56 for the overall SES-CD score, with larger scores indicating greater severity of disease. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Time Frame

Week 12

Title

Change in Roberts Intestinal Histopathology Index From Baseline (Paired Segments) at Week 12

Description

Changes in intestinal mucosa histopathologic features and disease activity were assessed by blinded pathologists. Robarts Histopathology Index (RHI) had a maximum total score of 165, with higher scores indicating more severe histological disease. Baseline was defined as the last non-missing record on or before the first dose of study drug.

Time Frame

Week 12

Title

Improvement in Perianal and Enterocutaneous Fistulas

Description

The assessment is based on two parameters: whether the fistula is draining and whether it's open or closed. This is assessment was only on participants that had a fistula at baseline.

Time Frame

Week 12

Title

Percentage of Participants Who Achieved Endoscopic Remission Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Definitions at Week 52 - Observed Cases

Description

Time Frame

Week 52

Title

Percentage of Participants Who Achieved an Endoscopic Response-50 Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Definitions at Week 52

Description

Time Frame

Week 52

Title

Percentage of Participants Who Achieved Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 52

Description

Clinical Remission is defined as a CDAI score of < 150. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Time Frame

Week 52

Title

Percentage of Participants Who Achieved a Clinical Response Based on CDAI at Week 52

Description

Clinical Response is defined as a CDAI reduction from baseline of ≥ 100 points. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Time Frame

Week 52

Title

Percentage of Participants Who Achieved Clinical Remission Based on Patient-Reported Outcome (PRO2) Measure Definitions at Week 52

Description

Clinical Remission is defined as the participants with the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point. The PRO2 is a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days and the abdominal pain (rated on a scale of 0-3) assessed for 7 days.

Time Frame

Week 52

Title

Percentage of Participants Who Achieved a Clinical Response Based on Patient Reported Outcome (PRO2) Measures From Baseline at Week 52

Description

Time Frame

Week 52

Title

Percentage of Participants in Clinical Remission Based on CDAI and PRO2 Definitions Who Were Off Corticosteroids at Week 52 of Those on Corticosteroids

Description

Clinical Remission is defined as CDAI score of < 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease. The CDAI uses a questionnaire with responses scored numerically and weighted. The weighted sum of the 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, general well-being for 7 days, presence of complications, taking diarrhea medication, abdominal mass, hematocrit and percentage deviation from standard weight. The typical range of CDAI score is 0 to > 600. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Time Frame

Week 52

Title

Percentage of Participants With Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Weeks 4 and 8

Description

Clinical Remission is defined as a CDAI score of < 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Time Frame

Weeks 4 and 8

Title

Percentage of Participants Who Achieved a Clinical Response Based on CDAI at Weeks 4 and 8

Description

Clinical Response is defined as a CDAI reduction from baseline of ≥ 100 points. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. 95% CI was created using the Clopper-Pearson Exact Method.

Time Frame

Weeks 4 and 8

Title

Percentage of Participants Who Achieved Clinical Remission Based on Patient-Reported Outcome (PRO2) Measure Definitions at Weeks 4 and 8

Description

Time Frame

Weeks 4 and 8

Title

Percentage of Participants Who Achieved a Clinical Response Based on Patient Reported Outcome (PRO2) Measures at Weeks 4 and 8

Description

Clinical response based on PRO2 was defined as PRO2 decrease of ≥50%. The PRO2 is a composite score based on 2 components of the Crohn's Disease Activity Index, the number of liquid or soft stools/day for 7 days and the abdominal pain (rated on a scale of 0-3) assessed for 7 days. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Time Frame

Weeks 4 and Week 8

Title

Percentage of Participants With RHI Healing at Week 52

Description

Changes from baseline in intestinal mucosa histopathologic features and disease activity were assessed by blinded pathologists. Robarts Histopathology Index (RHI) had a maximum total score of 165, with higher scores indicating more severe histological disease. Baseline was defined as the last non-missing record on or before the first dose of study drug. The Robarts Histopathology Index (RHI) is a recently validated instrument that measures histological disease activity in ulcerative colitis. RHI Mucosal Healing was defined as a composite endpoint of being a responder for endoscopic remission and RHI remission.

Time Frame

Week 52

Title

Change in Fecal Calprotectin (Observed Cases) at Weeks 12 and 52

Description

Change in fecal calprotectin (observed cases) determined by comparing measurements at weeks 12 and 52 to baseline measurement.

Time Frame

Baseline to Weeks 12 and Week 52

Title

Change in Serum C-Reactive Protein (CRP) Levels From Baseline (Observed Cases) at Weeks 12 and 52

Description

Change in Serum C-Reactive Protein was determined by comparing to baseline.

Time Frame

Baseline to Weeks 12 and 52

Title

Changes in Biomarkers: Percentage of Participants With CRP Response-10 - Non-responder Imputation

Description

The percentage of participants with a CRP Response-10 was assessed. CRP Response-10 is defined as C-reactive protein < 10 mg/L.

Time Frame

Week 12, Week 52

Title

Changes in Biomarkers: Percentage of Participants With FCP Response-250 - Non-responder Imputation

Description

The percentage of participants with a FCP Response-250 was assessed. FCP Response-250 is defined as Fecal calprotectin < 250 ug/g.

Time Frame

Week 12, Week 52

Title

Improvement in Perianal and Enterocutaneous Fistulas in Participants With Fistula's From Baseline at Weeks 4 and 8

Description

The assessment is based on two parameters: whether the fistula is draining and whether it's open or closed. This is assessment was only on participants that had a fistula at baseline.

Time Frame

Baseline to Week 4 and 8

Title

Pharmacokinetic Plasma Concentration of Ozanimod

Description

Summary of concentrations of Ozanimod in RPC01-2201 by scheduled visit.

Time Frame

From Day 1 to Week 52

Title

PK Plasma Concentration of Active Metabolite CC-112273

Description

Summary of concentrations of CC-112273 in RPC01-2201 by scheduled visit.

Time Frame

From Day 1 to Week 52

Title

Change From Baseline in Absolute Lymphocyte Count (ALC) Derived From Hematology Laboratory Results at Weeks 4, 8 and 12

Description

Change in Absolute Lymphocyte Count (ALC) from baseline was determined by comparied to baseline.

Time Frame

Baseline up to Weeks 4, 8 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kanthi Kollengode, MD

Organizational Affiliation

Celgene Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Adobe Clinical Research LLC

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Florida Center for Gastroenterology

City

Largo

State/Province

Florida

ZIP/Postal Code

33777

Country

United States

Facility Name

IMIC, Inc.

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Facility Name

Atlanta Gastroenterology Specialists PC

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Facility Name

DM Clinical Research

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453-3767

Country

United States

Facility Name

Gastroenterology Associates LLC

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Chevy Chase Clinical Research

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

Ehrhardt Clinical Research LLC

City

Belton

State/Province

Missouri

ZIP/Postal Code

64012

Country

United States

Facility Name

UC Health Clinical Trials Office

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

Ohio State University Clinical Trials Management Office

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Gastroenterology Associates of Orangeburg

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

Gastro One

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

San Antonio Gastroenterology

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

LHSC Victoria Hospital

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

Szent Margit Korhaz

City

Budapest

ZIP/Postal Code

H-1032

Country

Hungary

Facility Name

Tolna Megyei Balassa Janos Korhaz

City

Szekszárd

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Santa Familia Centrum Badan, Profilaktyki i Leczenia

City

Lodz

ZIP/Postal Code

90-302

Country

Poland

Facility Name

GASTROMED Sp.zo.o.

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

Centrum Zdrowia Matki, Dziecka i Mlodziezy

City

Warsaw

ZIP/Postal Code

00-632

Country

Poland

Facility Name

Centralny Szpital Kliniczny MSWIA

City

Warsaw

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Nzoz Vivamed

City

Warsaw

ZIP/Postal Code

03-580

Country

Poland

Facility Name

Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases

City

Dnipropetrovsk

ZIP/Postal Code

49074

Country

Ukraine

Facility Name

Kharkiv City Clinical Hospital 2

City

Kharkiv

ZIP/Postal Code

61037

Country

Ukraine

Facility Name

Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

City

Kyiv

ZIP/Postal Code

04107

Country

Ukraine

Facility Name

Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU

City

Kyiv

ZIP/Postal Code

1030

Country

Ukraine

Facility Name

Lviv Regional Clinical Hospital

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Vinnytsia Regional Clinical

City

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

CI City Hospital #1

City

Zaporizhia

ZIP/Postal Code

69104

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

32553149

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.

Results Reference

derived

Learn more about this trial

Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease

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