A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

— VEGA  

Official title:

A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662542
• Other study ID #: CR108527
• Secondary ID: 2018-001510-15CN
• Status: Completed
• Phase: Phase 2
• Start date: November 20, 2018
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: November 15, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before screening

• Moderately to severely active UC as defined by Mayo score

• History of inadequate response to or failure to tolerate conventional therapy

• Has screening laboratory test results within the study protocol defined parameters

• A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin) pregnancy test result at screening and a negative urine pregnancy test result at Week 0

Exclusion Criteria:

• Has severe extensive colitis as defined in the study protocol

• Has UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon

• Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening

• Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening)

• Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• Guselkumab Dose 1
Guselkumab Dose 1 will be administered as IV infusion.
• Guselkumab Dose 2
Guselkumab Dose 2 will be administered as SC injection.
• Golimumab Dose 1
Golimumab Dose 1 will be administered as SC injection.
• Golimumab Dose 2
Golimumab Dose 2 will be administered as SC injection.
• Placebo
Placebo will be administered.

Locations

Country	Name	City	State
Argentina	CEMIC (Centro de Educación Médica e Investigaciones Clínicas)	Buenos Aires
Argentina	Centro Médico Dra. De Salvo	Caba
Argentina	Expertia S.A	Caba
Argentina	Hospital Britanico de Buenos Aires	Ciudad Autonoma de Buenos Aires
Argentina	Clínica Adventista Belgrano	Ciudad De Buenos Aires
Argentina	Hospital de Alta Complejidad en Red 'El Cruce'	Florencio Varela
Argentina	Fundacion de Estudios Clinicos	Rosario
Argentina	Sanatorio 9 de Julio	San Miguel de Tucuman
Australia	Princess Alexandra Hospital	Brisbane
Australia	St Vincent's Hospital - Melbourne	Fitzroy
Australia	Nepean Hospital	Kingswood
Australia	Royal Adelaide Hospital	North Terrace
Australia	Macquarie University Hospital	NSW
Australia	Royal Melbourne Hospital	Parkville
Australia	Mater Hospital Brisbane (Inflammatory Bowel Diseases)	South Brisbane
Brazil	Hospital Das Clinicas Da Ufmg	Belo Horizonte
Brazil	Universidade Estadual Paulista 'Julio De Mesquita Filho'	Botucatu
Brazil	Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro	Goiania
Brazil	Hospital das Clinicas de Porto Alegre	Porto Alegre
Brazil	Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP	Ribeirao Preto
Brazil	Instituto Brasil de Pesquisa Clinica	Rio de Janeiro
Brazil	Universidade Federal do Rio de Janeiro - Faculdade de Medicina	Rio de Janeiro
Brazil	Fundacao do ABC - Centro Universitario FMABC	Santo Andre
Brazil	Kaiser Hospta	São José Do Rio Preto
Brazil	Eurolatino Pesquisas Medicas Ltda	Uberlandia
Germany	Charite Berlin	Berlin
Germany	Universitatsklinikum Frankfurt/ Medizinische Klinik 1	Frankfurt
Germany	Universitätsklinikum Jena	Jena
Germany	Universitaetsklinikum Ulm	Ulm
Mexico	Clínica Saluz	Boca del Rio
Mexico	Clinicos Asociados BOCM, SC	Mexico City
Mexico	Centro Regiomontano de Estudios Clínicos Roma S.C.	Monterrey
Mexico	Capital Humano para la Investigacion clinica	Queretaro
Mexico	Centro Medico Zambrano Hellion	San Pedro Garza Garcia
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdansku	Gdansk
Poland	Pratia MCM Krakow	Krakow
Poland	Endoskopia Sp. z o.o. z siedziba w Sopocie	Sopot
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warsaw
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz	Warszawa
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warszawa
Poland	Melita Medical Sp. z o.o.	Wroclaw
Russian Federation	Medical Association 'New Hospital'	Ekaterinburg
Russian Federation	Kazan State Medical University	Kazan
Russian Federation	City Clinical Hospital # 24	Moscow
Russian Federation	Medical Center SibNovoMed LLC	Novosibirsk
Russian Federation	Rostov State Medical University	Rostov-On-Don
Russian Federation	City Clinical Hospital #31	Saint Petersburg
Russian Federation	Elizavetinskaya hospital	Saint Petersburg
Russian Federation	Eco-safety Ltd	Saint-Petersburg
Russian Federation	Medical University Reaviz	Samara
Russian Federation	International Medical Centre SOGAZ	St-Petersburg
Russian Federation	Tver Regional Clinical Hospital	Tver
Russian Federation	GBUZ Respublican Clinical Hospital n.a. GG Kuvatova	Ufa
Russian Federation	City Clinical Hospital #2	Yaroslavl
Russian Federation	Regional Clinical Hospital	Yaroslavl
Ukraine	Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'	Kharkiv
Ukraine	SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine	Kharkiv
Ukraine	Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'	Kherson
Ukraine	Kyiv City Clinical Hospital #18	Kyiv
Ukraine	Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'	Kyiv
Ukraine	Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'	Lviv
Ukraine	Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway	Lviv
Ukraine	Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council	Odessa
Ukraine	Sumy State University, Sumy Regional Clinical Hospital	Sumy
Ukraine	Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'	Ternopil
Ukraine	Medical Center Ltd 'Health Clinic', Department Of General Therapy	Vinnytsya
Ukraine	Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov	Vinnytsya
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Fargo Gastroenterology Clinic, PC	Fargo	North Dakota
United States	Woodholme Gastroenterology	Glen Burnie	Maryland
United States	Indiana University	Indianapolis	Indiana
United States	Sierra Clinical Research	Las Vegas	Nevada
United States	Gastrointestinal Specialists of Georgia	Marietta	Georgia
United States	Precision Research Institute	San Diego	California
United States	Virginia Mason	Seattle	Washington
United States	Texas Digestive Disease Consultants	Southlake	Texas
United States	Washington Gastroenterology, PLLC	Tacoma	Washington
United States	GCP Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Germany,  Mexico,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12	Clinical response was defined as a decrease from baseline in the Mayo score greater than or equal to (>=) 30 percent (%) and >=3 points with either a decrease from baseline in the rectal bleeding subscore (RBS) >=1 or a RBS of 0 or 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.	Week 12
Secondary	Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12	Clinical remission was defined as the Mayo score less than or equal to (<=) 2 with no individual subscore greater than (>) 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings) each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.	Week 12