Efficacy and Safety Study of Ozanimod in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— Touchstone  

Official title:

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647516
• Other study ID #: RPC01-202
• Status: Completed
• Phase: Phase 2
• Start date: December 26, 2012
• Est. completion date: August 30, 2019

Study information

• Verified date: May 2021
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: August 30, 2019
• Est. primary completion date: March 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 73 Years

Eligibility

Inclusion Criteria:

• Ulcerative colitis (UC) confirmed on endoscopy

• Moderately to severely active UC (Mayo score 6-12)

Exclusion Criteria:

• Current use of anti-TNF agents

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Ozanimod
Ozanimod capsules by mouth daily.
• Placebo

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
Belgium	Universitair Ziekenhuis Leuven, Campus Gasthuisberg	Leuven
Bulgaria	Multiprofile Hospital for Active Treatment Kaspela	Plovdiv
Bulgaria	Military Medical Academy	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment Doverie AD	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment Sofiamed	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment Sveti Panteleimon - Sofia AD	Sofia
Bulgaria	UMHAT Sv Ivan Rilski EAD	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment Sveta Marina EAD	Varna
Canada	London Health Sciences Centre, University Hospital	London	Ontario
Greece	Evaggelismos General Hospital	Athens
Greece	University Hospital of Ioannina	Ioannina
Greece	University Hospital of Larissa	Larissa
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest
Hungary	Pannonia Maganorvosi Centrum	Budapest
Hungary	Uzsoki Utcai Korhaz	Budapest
Hungary	Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja	Debrecen
Israel	Barzilai Medical Center	Ashkelon
Israel	Carmel Medical Center	Haifa
Israel	Wolfson Medical Center	Holon
Israel	Hadassah University Hospital	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Konyang University Hospital	Daejon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Medical Center	Seoul
Korea, Republic of	Kyunghee University Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, St.Vicent's Hospital	Suwon
Korea, Republic of	Wonju Christian Hospital	Wonju
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Ikazia Ziekenhuis	Rotterdam
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Waikato Hospital	Hamilton
New Zealand	Hutt Valley District Health Board	Lower Hutt
New Zealand	North Shore Hospital	Milford
Poland	SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego	Bialystok
Poland	Niepubliczny Zaklad Opieki Zdrowotnej INTERMED	Czestochowa
Poland	Elblaski Szpital Specjalistyczny z Przychodnia	Elblag
Poland	Przychodnia Lekarska Nowy Chelm	Gdansk
Poland	Economicus - NZOZ ALL-MEDICUS	Katowice
Poland	Centrum Opieki Zdrowotnej Orkan Med	Ksawerow
Poland	Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny	Lodz
Poland	Instytut Medycyny Wsi	Lublin
Poland	MEDICOR Centrum Medyczne	Rzeszow
Poland	Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED	Warsaw
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Triclinium	Warszawa
Poland	LexMedica Osrodek Badan Klinicznych	Wroclaw
Russian Federation	Regional Clinical Hospital	Krasnoyarsk
Russian Federation	SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov of the MoH of the RF	Moscow
Russian Federation	Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko	Nizhniy Novgorod
Russian Federation	Novosibirsk State Medical University	Novosibirsk
Russian Federation	SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF	Omsk
Russian Federation	SEIHPE Rostov State Medical University of MoH of RF	Rostov on Don
Russian Federation	City Hospital 26	Saint Petersburg
Russian Federation	Russian Medical Military Academy na SMKirov	Saint Petersburg
Russian Federation	Medical Company Hepatolog	Samara
Slovakia	Slovak Research Center	Ilava
Slovakia	Specializovana Nemocnica Svorada Zobor	Nitra
Slovakia	GASTRO I., s.r.o.	Presov
Ukraine	Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU	Ivano-Frankivsk
Ukraine	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivsk
Ukraine	Institute of Therapy n.a. L.T. Maloy of NAMS of Ukraine	Kharkiv
Ukraine	CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv	Kyiv
Ukraine	Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE	Kyiv
Ukraine	Order of the Red Star MMMCC MMCH Clinic of Gastroenterology	Kyiv
Ukraine	Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU	Lviv
Ukraine	Lviv Regional Clinical Hospital	Lviv
Ukraine	Vinnytsia Regional Clinical	Vinnytsia
Ukraine	Medical Clinical Research Center "Health Clinic"	Vinnytsya
Ukraine	Municipal Institution Zaporizhzhia	Zaporizhzhia
Ukraine	Zaporizhzhya city multidisciplinary clinical hospital #9	Zaporizhzhya
United States	Anaheim Clinical Trials	Anaheim	California
United States	Atlanta Gastroenterology Associates, LLC	Atlanta	Georgia
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	University of California San Diego	La Jolla	California
United States	Alliance Clinical Research	Oceanside	California
United States	Endoscopic Microsurgery Associates	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  Greece,  Hungary,  Israel,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Russian Federation,  Slovakia,  Ukraine, 

References & Publications (1)

Sandborn WJ, Feagan BG, Wolf DC, D'Haens G, Vermeire S, Hanauer SB, Ghosh S, Smith H, Cravets M, Frohna PA, Aranda R, Gujrathi S, Olson A; TOUCHSTONE Study Group. Ozanimod Induction and Maintenance Treatment for Ulcerative Colitis. N Engl J Med. 2016 May 5;374(18):1754-62. doi: 10.1056/NEJMoa1513248. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8	Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point.; The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.; Stool Frequency Subscore (SFS); Rectal bleeding Subscore (RBS); Endoscopy Subscore; Physician's Global Assessment (PGA); Clinical Remission was based on the 4-component Mayo definition.	Week 8
Secondary	Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8	Clinical response was defined as a reduction from baseline in Mayo score =3 points and =30%, and a decrease from baseline in the rectal bleeding subscore of = 1 point or an absolute rectal bleeding subscore of = 1 point.; The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.; Clinical Respone was based on the 4-component Mayo definition.	Week 8
Secondary	Change From Baseline in Mayo Score at Week 8	The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.; Stool Frequency Subscore (SFS); Rectal bleeding Subscore (RBS); Endoscopy Subscore; Physician's Global Assessment (PGA)	Baseline to Week 8
Secondary	Percentage of Participants With Mucosal Healing at Week 8	Mucosal healing is defined as an endoscopy subscore = 1 point. Endoscopy subscores were calculated based on central endoscopy reading.; The endoscopy scale: 0 = Normal or inactive disease; = Mild disease (erythema, decreased vascular pattern, mild friability); = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); = Severe disease (spontaneous bleeding, ulceration)	Week 8
Secondary	Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32	Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point.; The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.; Stool Frequency Subscore (SFS); Rectal bleeding Subscore (RBS); Endoscopy Subscore; Physician's Global Assessment (PGA)	Week 32
Secondary	Percentage of Participants Who Achieved Clinical Response at Week 32	Clinical response was defined as a reduction from baseline in Mayo score =3 points and =30%, and a decrease from baseline in the rectal bleeding subscore of = 1 point or an absolute rectal bleeding subscore of = 1 point.; The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.; Stool Frequency Subscore (SFS); Rectal bleeding Subscore (RBS); Endoscopy Subscore; Physician's Global Assessment (PGA)	Week 32
Secondary	Percentage of Participants With Mucosal Healing at Week 32	Mucosal healing is defined as an endoscopy subscore = 1 point. Endoscopy subscores were calculated based on central endoscopy reading.; The endoscopy scale: 0 = Normal or inactive disease; = Mild disease (erythema, decreased vascular pattern, mild friability); = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); = Severe disease (spontaneous bleeding, ulceration)	Week 32
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period	A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.	From the first dose of investigational product (IP) up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 52.8 days, 56.1 days and 50.8 days respectively for 0.5 mg, 1 mg ozanimod and placebo
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period	A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.	From the first dose of IP up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo.
Secondary	Number of Participants With TEAE During the Open-Label Treatment Period (OLP)	A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.	From the first dose of IP until 90 days after the last dose of IP or at follow-up visit; the mean total duration of study drug exposure in the OLP was 2.42 years