Back to resultsA Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (VEGA)
Primary Purpose
Colitis, Ulcerative
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Guselkumab Dose 1
Guselkumab Dose 2
Golimumab Dose 1
Golimumab Dose 2
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Colitis, Ulcerative
Eligibility Criteria
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
Sites / Locations
- Precision Research Institute
- Peak Gastroenterology Associates
- GCP Clinical Research
- Gastrointestinal Specialists of Georgia
- Indiana University
- Chevy Chase Clinical Research
- Woodholme Gastroenterology
- Sierra Clinical Research
- The University of North Carolina at Chapel Hill
- Fargo Gastroenterology Clinic, PC
- Texas Digestive Disease Consultants
- Gastroenterology Associates of Tidewater
- Virginia Mason
- Washington Gastroenterology, PLLC
- CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
- Expertia S.A
- Centro Médico Dra. De Salvo
- Hospital Britanico de Buenos Aires
- Clínica Adventista Belgrano
- Hospital de Alta Complejidad en Red 'El Cruce'
- Fundación de Estudios Clínicos
- Sanatorio 9 de Julio
- Princess Alexandra Hospital
- St Vincent's Hospital - Melbourne
- Nepean Hospital
- Royal Adelaide Hospital
- Macquarie University Hospital
- Royal Melbourne Hospital
- Mater Hospital Brisbane (Inflammatory Bowel Diseases)
- Hospital Das Clinicas Da Ufmg
- Universidade Estadual Paulista 'Julio De Mesquita Filho'
- Clinica De Gastroenterologia
- Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
- UFRJ-Hospital Universitário Clementino Fraga Filho
- Instituto Brasil de Pesquisa Clinica
- Faculdade de Medicina Do Abc
- Kaiser Hospta
- Eurolatino Pesquisas Médicas
- Charite Berlin
- Universitätsklinikum Frankfurt/ Medizinische Klinik 1
- Universitätsklinikum Jena
- Universitaetsklinikum Ulm
- Clínica Saluz
- Clinicos Asociados BOCM, SC
- Centro Regiomontano de Estudios Clínicos Roma S.C.
- Capital Humano para la Investigacion clinica
- Centro Medico Zambrano Hellion
- Synexus Polska Sp. z o.o. Oddzial w Gdansku
- Pratia MCM Krakow
- Endoskopia Sp. z o.o. z siedzibą w Sopocie
- Centralny Szpital Kliniczny MSWiA w Warszawie
- Centrum Zdrowia MDM
- WIP Warsaw IBD Point Profesor Kierkus
- Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
- Melita Medical Sp. z o.o.
- Medical Association 'New Hospital'
- Kazan State Medical University
- City Clinical Hospital # 24
- Medical Center SibNovoMed LLC
- Rostov State Medical University
- Elizavetinskaya hospital
- City Clinical Hospital #31
- Eco-safety Ltd
- Medical University Reaviz
- International Medical Centre SOGAZ
- Tver Regional Clinical Hospital
- GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
- City Clinical Hospital #2
- Regional Clinical Hospital
- Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'
- SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine'
- Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'
- Kyiv City Clinical Hospital #18
- Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
- Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway
- Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
- Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
- Sumy State University, Sumy Regional Clinical Hospital
- Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
- Medical Center Ltd 'Health Clinic', Department Of General Therapy
- Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Combination Therapy
Monotherapy: Guselkumab
Monotherapy: Golimumab
Arm Description
Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Outcomes
Primary Outcome Measures
Clinical Response at Week 12
Clinical response as defined by Mayo score. The Mayo score is 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.
Secondary Outcome Measures
Clinical Remission at Week 12
Clinical remission as defined by Mayo score. The Mayo score is 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.
Full Information
NCT ID
NCT03662542
First Posted
September 6, 2018
Last Updated
December 30, 2021
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03662542
Brief Title
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
November 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
214 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination Therapy
Arm Type
Experimental
Arm Description
Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Arm Title
Monotherapy: Guselkumab
Arm Type
Experimental
Arm Description
Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Arm Title
Monotherapy: Golimumab
Arm Type
Active Comparator
Arm Description
Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Intervention Type
Drug
Intervention Name(s)
Guselkumab Dose 1
Intervention Description
Guselkumab Dose 1 will be administered as IV infusion.
Intervention Type
Drug
Intervention Name(s)
Guselkumab Dose 2
Intervention Description
Guselkumab Dose 2 will be administered as SC injection.
Intervention Type
Drug
Intervention Name(s)
Golimumab Dose 1
Intervention Description
Golimumab Dose 1 will be administered as SC injection.
Intervention Type
Drug
Intervention Name(s)
Golimumab Dose 2
Intervention Description
Golimumab Dose 2 will be administered as SC injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered.
Primary Outcome Measure Information:
Title
Clinical Response at Week 12
Description
Clinical response as defined by Mayo score. The Mayo score is 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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Clinical Remission at Week 12
Description
Clinical remission as defined by Mayo score. The Mayo score is 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.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Precision Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
GCP Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Woodholme Gastroenterology
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Sierra Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Fargo Gastroenterology Clinic, PC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Virginia Mason
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Washington Gastroenterology, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Expertia S.A
City
Caba
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
Centro Médico Dra. De Salvo
City
Caba
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Clínica Adventista Belgrano
City
Ciudad De Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Hospital de Alta Complejidad en Red 'El Cruce'
City
Florencio Varela
ZIP/Postal Code
1888
Country
Argentina
Facility Name
Fundación de Estudios Clínicos
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Sanatorio 9 de Julio
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Princess Alexandra Hospital
City
Brisbane
ZIP/Postal Code
4102
Country
Australia
Facility Name
St Vincent's Hospital - Melbourne
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
ZIP/Postal Code
2747
Country
Australia
Facility Name
Royal Adelaide Hospital
City
North Terrace
ZIP/Postal Code
5000
Country
Australia
Facility Name
Macquarie University Hospital
City
NSW
ZIP/Postal Code
2109
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
Mater Hospital Brisbane (Inflammatory Bowel Diseases)
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Facility Name
Hospital Das Clinicas Da Ufmg
City
Belo Horizonte
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Universidade Estadual Paulista 'Julio De Mesquita Filho'
City
Botucatu
ZIP/Postal Code
18618-970
Country
Brazil
Facility Name
Clinica De Gastroenterologia
City
Goiania
ZIP/Postal Code
74535-170
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
City
Ribeirão Preto
ZIP/Postal Code
14098-900
Country
Brazil
Facility Name
UFRJ-Hospital Universitário Clementino Fraga Filho
City
Rio de Janeiro
ZIP/Postal Code
20050-902
Country
Brazil
Facility Name
Instituto Brasil de Pesquisa Clinica
City
Rio de Janeiro
ZIP/Postal Code
20241-180
Country
Brazil
Facility Name
Faculdade de Medicina Do Abc
City
Santo Andre
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Kaiser Hospta
City
São José Do Rio Preto
ZIP/Postal Code
15015-110
Country
Brazil
Facility Name
Eurolatino Pesquisas Médicas
City
Uberlândia
ZIP/Postal Code
38400-368
Country
Brazil
Facility Name
Charite Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitätsklinikum Frankfurt/ Medizinische Klinik 1
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Clínica Saluz
City
Boca del Rio
ZIP/Postal Code
94229
Country
Mexico
Facility Name
Clinicos Asociados BOCM, SC
City
Mexico City
ZIP/Postal Code
03300
Country
Mexico
Facility Name
Centro Regiomontano de Estudios Clínicos Roma S.C.
City
Monterrey
ZIP/Postal Code
64610
Country
Mexico
Facility Name
Capital Humano para la Investigacion clinica
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Centro Medico Zambrano Hellion
City
San Pedro Garza Garcia
ZIP/Postal Code
66278
Country
Mexico
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdansku
City
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Pratia MCM Krakow
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Endoskopia Sp. z o.o. z siedzibą w Sopocie
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
City
Warszawa
ZIP/Postal Code
03 580
Country
Poland
Facility Name
Melita Medical Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
50-449
Country
Poland
Facility Name
Medical Association 'New Hospital'
City
Ekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
Kazan State Medical University
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
City Clinical Hospital # 24
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Medical Center SibNovoMed LLC
City
Novosibirsk
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-On-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Elizavetinskaya hospital
City
Saint Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
City Clinical Hospital #31
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Eco-safety Ltd
City
Saint-Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
Medical University Reaviz
City
Samara
ZIP/Postal Code
443001
Country
Russian Federation
Facility Name
International Medical Centre SOGAZ
City
St-Petersburg
ZIP/Postal Code
191186
Country
Russian Federation
Facility Name
Tver Regional Clinical Hospital
City
Tver
ZIP/Postal Code
170036
Country
Russian Federation
Facility Name
GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
City Clinical Hospital #2
City
Yaroslavl
ZIP/Postal Code
150010
Country
Russian Federation
Facility Name
Regional Clinical Hospital
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine'
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'
City
Kherson
ZIP/Postal Code
73003
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #18
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway
City
Lviv
ZIP/Postal Code
79007
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Sumy State University, Sumy Regional Clinical Hospital
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Medical Center Ltd 'Health Clinic', Department Of General Therapy
City
Vinnytsya
ZIP/Postal Code
21009
Country
Ukraine
Facility Name
Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
We'll reach out to this number within 24 hrs