A Study of Efficacy and Safety of Combination Therapy Wit... | NCT03662542

NCT03662542

ID	Type	Description	Link
2018-001510-15	EudraCT Number
CNTO1959UCO2002	Other Identifier	Janssen Research & Development, LLC

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Combination Therapy	Experimental	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.	Drug: Guselkumab Dose 1 Drug: Guselkumab Dose 2 Drug: Golimumab Dose 1 Drug: Golimumab Dose 2 Drug: Placebo
Monotherapy: Guselkumab	Experimental	Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.	Drug: Guselkumab Dose 1 Drug: Guselkumab Dose 2 Drug: Placebo
Monotherapy: Golimumab	Active Comparator	Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.	Drug: Golimumab Dose 1 Drug: Golimumab Dose 2 Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Guselkumab Dose 1	Drug	Guselkumab Dose 1 will be administered as IV infusion.	Combination Therapy Monotherapy: Guselkumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Precision Research Institute		San Diego	California	92114	United States
Peak Gastroenterology Associates

PubMed Identifier	Type	Citation	Retractions
38488354	Derived	Shao J, Vetter M, Vermeulen A, Feagan BG, Sands BE, Panes J, Xu Z. Combination Therapy With Guselkumab and Golimumab in Patients With Moderately to Severely Active Ulcerative Colitis: Pharmacokinetics, Immunogenicity and Drug-Drug Interactions. Clin Pharmacol Ther. 2024 Jun;115(6):1418-1427. doi: 10.1002/cpt.3235. Epub 2024 Mar 15.
36738762

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Combination Phase: Golimumab Monotherapy	Participants received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 7, 2019	Nov 17, 2023

Arm/Group Information

ID	Title	Description
BG000	Golimumab Monotherapy	Participants received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0 followed by golimumab 100 mg as SC injection at Weeks 2, 6, 10, 14, 18, 22, 26, 30 and 34. Participants received placebo as intravenous (IV) infusion as Weeks 0, 4, 8 and as SC injection at Weeks 16, 24, 32 to maintain the blind. Participants were then followed up for safety from Week 38 to Week 50 (end of study [EOS]).
BG001	Guselkumab Monotherapy	Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8 followed by guselkumab 100 mg as SC injection at Weeks 16, 24 and 32. Participants received placebo as SC injection at Weeks 0, 2, 6, 10, 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then followed up for safety from Week 38 to Week 50 (EOS).
BG002	Combination Therapy	Participants received guselkumab 200 mg as IV infusion followed by golimumab 200 mg as SC injection at Weeks 0. Participants received guselkumab 200 mg as IV infusion at Weeks 4 and 8, golimumab 100 mg as SC injection at Weeks 2, 6 and 10 and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then followed up for safety from Week 38 to Week 50 (EOS).
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00038.1± 10.47 BG00139.1± 13.67 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00030 BG00131 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0016 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

ARGENTINA

Title	Measurements
	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Efficacy analyses were based on the full analysis set (FAS), which included all randomized participants who received at least 1 (partial or complete) dose of study intervention.

Posted

Number

Percentage of participants

Week 12

ID	Title	Description
OG000	Combination Phase: Golimumab Monotherapy	Participants received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
OG001	Combination Phase: Guselkumab Monotherapy	Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8. Participants received placebo as SC injection at Weeks 0, 2, 6 and 10 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
OG002	Combination Phase: Combination Therapy	Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4, and 8. Participants received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants were then assessed for efficacy at Week 10 and Week 12.

Units	Counts
Participants	OG00072 OG00171 OG00271

Title

Denominators

Categories

Title	Measurements
	OG00061.1 OG00174.6 OG00283.1

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.

Efficacy analyses were based on the FAS, which included all randomized participants who received at least 1 (partial or complete) dose of study intervention.

Posted

Number

Percentage of participants

Week 12

ID	Title	Description
OG000	Combination Phase: Golimumab Monotherapy	Participants received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
OG001	Combination Phase: Guselkumab Monotherapy

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Combination Phase: Golimumab Monotherapy	Participants received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.	0	72	1	72	19	72
EG001	Combination Phase: Guselkumab Monotherapy	Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8. Participants received placebo as SC injection at Weeks 0, 2, 6 and 10 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.	0	71	2	71	16	71
EG002	Combination Phase: Combination Therapy	Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4, and 8. Participants received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants were then assessed for efficacy at Week 10 and Week 12.	0	71	1	71	14	71
EG003	Monotherapy Phase: Golimumab Monotherapy	Participants received golimumab 100 mg as SC injection at Weeks 14, 18, 22, 26, 30 and 34, and placebo as SC injection at Weeks 16, 24, and 32 to maintain the blind. Participants were then assessed for efficacy at Week 38.	0	67	3	67	12	67
EG004	Monotherapy Phase: Guselkumab Monotherapy	Participants received guselkumab 100 mg as SC injection at Weeks 16, 24, and 32, and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then assessed for efficacy at Week 38.	0	70	1	70	16	70
EG005	Monotherapy Phase: Combination Therapy	Participants received guselkumab 100 mg as SC injection at Weeks 16, 24 and 32, and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then assessed for efficacy at Week 38.	1	71	3	71	14	71
EG006	Safety Follow-up: Golimumab Monotherapy	Participants were followed up for safety from Week 38 to Week 50 (end of study [EOS]) and did not receive any additional medication in the safety follow-up phase.	0	58	0	58	3	58
EG007	Safety Follow-up: Guselkumab Monotherapy	Participants were followed up for safety from Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.	1	65	2	65	2	65
EG008	Safety Follow-up: Combination Therapy	Participants were followed up for safety from Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.	0	60	0	60	0	60

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial Fibrillation	Cardiac disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0011 affected71 at risk EG0020 affected71 at risk EG0030 affected67 at risk EG0040 affected70 at risk EG0050 affected71 at risk EG0060 affected58 at risk EG0070 affected65 at risk EG0080 affected60 at risk
Colitis Ulcerative	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected72 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0011 affected71 at risk EG0020 affected71 at risk EG003
Bronchitis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Chronic Sinusitis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Covid-19	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Covid-19 Pneumonia	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Influenza	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected71 at risk EG0021 affected71 at risk EG003
Sepsis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected71 at risk EG0021 affected71 at risk EG003
Tuberculosis of Intrathoracic Lymph Nodes	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Poisoning	Injury, poisoning and procedural complications	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Adenocarcinoma of Colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0005 affected72 at risk EG0016 affected71 at risk EG0024 affected71 at risk EG0032 affected67 at risk EG0046 affected70 at risk EG0050 affected71 at risk EG0060 affected58 at risk EG0071 affected65 at risk EG0080 affected60 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0002 affected72 at risk EG0014 affected71 at risk EG0022 affected71 at risk EG003
Colitis Ulcerative	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0008 affected72 at risk EG0011 affected71 at risk EG0024 affected71 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0004 affected72 at risk EG0015 affected71 at risk EG0021 affected71 at risk EG003
Headache	Nervous system disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0002 affected72 at risk EG0013 affected71 at risk EG0024 affected71 at risk EG003

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases