A Study of Guselkumab in Participants With Active Psoriat... | NCT04882098

ID	Type	Description
CNTO1959PSA3004	Other Identifier	Janssen Research & Development, LLC
2020-004981-20	EudraCT Number
2023-504734-21-00	Registry Identifier	EUCT number

Label	Type	Description	Intervention Names
Group 1: Guselkumab and Placebo	Experimental	Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. Participants who have not discontinued will be eligible to enter a long-term extension (LTE) and will receive guselkumab and placebo SC. After the study is unblinded to the investigative sites, participants will receive guselkumab and no longer be required to dose with placebo to maintain the blind.	Drug: Guselkumab Drug: Placebo
Group 2: Guselkumab	Experimental	Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.	Drug: Guselkumab
Group 3: Placebo Followed by Guselkumab	Experimental	Participants will receive placebo SC and will cross over to receive SC guselkumab. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.	Drug: Guselkumab Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Guselkumab	Drug	Participants will receive guselkumab as SC injection.	Group 1: Guselkumab and Placebo Group 2: Guselkumab Group 3: Placebo Followed by Guselkumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24	ACR 20 response: >=20% improvement from baseline (bl) in both swollen (66 joints), tender (68 joints) joint count, >=20% improvement from bl in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100mm, 0=no pain, 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100mm, 0=excellent, 100=poor), physician's global assessment of disease activity (VAS; 0-100mm, 0=no arthritis activity,100=extremely active arthritis), HAQ-DI (questionnaire assessing 8 functional areas; 0-3, 0=no difficulty, 3=inability to perform task in area), and CRP. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Composite-discontinue study drug not due to ND/MD, initiate/increase DMARD/oral corticosteroid, initiate prohibited PsA treatment; Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD.	At Week 24

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24	Modified vdH-S score was sum of erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score was total erosion severity in 40 joints of 2 hands and 12 joints of 2 feet, maximum erosion score=320. Each hand joint was scored on 0 to 5 with 0 =no erosion, 5 =complete collapse of bone. Foot joint was scored on 0 to 10, 0 =no erosion, 10 =complete collapse of bone. JSN score was total JSN score in same 52 joints, each joint scored on 0 to 4 with 0 indicating no JSN, and 4 indicating absence of joint space, maximum JSN score=208. Maximum modified vdH-S score=528. Higher score =severe structural destruction and complete loss of joint spaces. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Rheumatology Associates		Birmingham	Alabama	35205	United States
Arizona Arthritis and Rheumatology Research PLLC

PubMed Identifier	Type	Citation	Retractions
36627711	Derived	Ritchlin CT, Coates LC, Mease PJ, van der Heijde D, Song J, Jiang Y, Shawi M, Kollmeier AP, Rahman P. The effect of guselkumab on inhibiting radiographic progression in patients with active psoriatic arthritis: study protocol for APEX, a Phase 3b, multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2023 Jan 10;24(1):22. doi: 10.1186/s13063-022-06945-y.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group 1: Guselkumab 100 mg q8w	Participants received guselkumab 100 milligram (mg) subcutaneous (SC) injection at Weeks 0 and 4, then every 8 weeks (q8w) starting from Week 12 through Week 44 and placebo matched to guselkumab SC injections q8w starting from Week 8 through Week 48 to maintain the blind. After the Week 48 database lock and subsequent full unblinding, placebo injections were no longer required. At Week 48, eligible participants had the option to enter a long-term extension (LTE) and continued to receive guselkumab 100 mg SC injection every 4 weeks (q4w) up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.

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	May 4, 2022	Dec 23, 2025

Arm/Group Information

ID	Title	Description
BG000	Group 1: Guselkumab 100 mg q8w	Participants received guselkumab 100 mg SC injection at Weeks 0 and 4, then q8w starting from Week 12 through Week 44 and placebo matched to guselkumab SC injections q8w starting from Week 8 through Week 48 to maintain the blind. After the Week 48 database lock and subsequent full unblinding, placebo injections were no longer required. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection every q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.
BG001	Group 2: Guselkumab 100 mg q4w	Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.
BG002	Group 3: Placebo Followed by Guselkumab	Participants received placebo matched to guselkumab SC injections q4w starting from Week 0 through Week 20. Participants then crossed over and received guselkumab 100 mg SC injections q4w from Week 24 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.
BG003	Total	Total of all reporting groups

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

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24

ACR 20 response: >=20% improvement from baseline (bl) in both swollen (66 joints), tender (68 joints) joint count, >=20% improvement from bl in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100mm, 0=no pain, 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100mm, 0=excellent, 100=poor), physician's global assessment of disease activity (VAS; 0-100mm, 0=no arthritis activity,100=extremely active arthritis), HAQ-DI (questionnaire assessing 8 functional areas; 0-3, 0=no difficulty, 3=inability to perform task in area), and CRP. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Composite-discontinue study drug not due to ND/MD, initiate/increase DMARD/oral corticosteroid, initiate prohibited PsA treatment; Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD.

Analysis population is Modified FAS (mFAS). Participants who achieved ACR 20 response at Week 24 and did not meet any Composite Strategy ICEs before Week 24 were considered as responders. Participants who met any Composite Strategy ICEs before Week 24 were considered non-responders. Participants who met Hypothetical Strategy ICEs, or missed data due to ND/MD, had affected visits imputed using multiple imputation. Other missing data were imputed as non-responders.

Posted

Number

percentage of participants

At Week 24

ID	Title	Description
OG000	Group 1: Guselkumab 100 mg q8w	Participants received guselkumab 100 mg SC injection at Weeks 0 and 4, then q8w starting from Week 12 through Week 44 and placebo matched to guselkumab SC injections q8w starting from Week 8 through Week 48 to maintain the blind. After the Week 48 database lock and subsequent full unblinding, placebo injections were no longer required. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection every q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.
OG001	Group 2: Guselkumab 100 mg q4w	Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.
OG002	Group 3: Placebo Followed by Guselkumab	Participants received placebo matched to guselkumab SC injections q4w starting from Week 0 through Week 20. Participants then crossed over and received guselkumab 100 mg SC injections q4w from Week 24 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.

Units	Counts
Participants	OG000371 OG001273 OG002376

Title

Denominators

Categories

Title	Measurements
	OG00068.3 OG00166.6 OG00247.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Cochran-Mantel-Haenszel		<0.001		Difference in percentage	21.3			2-Sided	95	14.4	28.2					Superiority
OG001 OG002		Cochran-Mantel-Haenszel		<0.001

Secondary

Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24

Modified vdH-S score was sum of erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score was total erosion severity in 40 joints of 2 hands and 12 joints of 2 feet, maximum erosion score=320. Each hand joint was scored on 0 to 5 with 0 =no erosion, 5 =complete collapse of bone. Foot joint was scored on 0 to 10, 0 =no erosion, 10 =complete collapse of bone. JSN score was total JSN score in same 52 joints, each joint scored on 0 to 4 with 0 indicating no JSN, and 4 indicating absence of joint space, maximum JSN score=208. Maximum modified vdH-S score=528. Higher score =severe structural destruction and complete loss of joint spaces. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD

Modified full analysis set included all participants who were randomized, excluding participants from Ukrainian sites rendered unable to support key study operations due to major disruption. Participants who met Hypothetical Strategy ICEs had affected visits imputed using multiple imputation. Missing data were also imputed using multiple imputation.

Posted

Least Squares Mean

95% Confidence Interval

Score on a scale

Baseline (after first administration of study drug) and Week 24

ID	Title	Description
OG000	Group 1: Guselkumab 100 mg q8w	Participants received guselkumab 100 mg SC injection at Weeks 0 and 4, then q8w starting from Week 12 through Week 44 and placebo matched to guselkumab SC injections q8w starting from Week 8 through Week 48 to maintain the blind. After the Week 48 database lock and subsequent full unblinding, placebo injections were no longer required. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection every q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Not Posted

Dec 2029