NCT03818035 (GUIDE) is a Phase 3 clinical trial of Guselkumab in Psoriasis, sponsored by Janssen-Cilag International NV.

Who is sponsoring NCT03818035?

NCT03818035 is sponsored by Janssen-Cilag International NV.

What drugs are being tested in NCT03818035?

Interventions in NCT03818035: Guselkumab, Placebo Injection.

Is NCT03818035 still recruiting?

NCT03818035 is currently completed. Last updated 23 January 2026.

Are results published for NCT03818035?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-01-23 · How we verify

NCT03818035: GUIDE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis

Completed Phase 3 Results posted Last updated 23 January 2026

What this trial tests

Phase 3 trial testing Guselkumab in Psoriasis in 880 participants. Completed in 7 January 2025.

Timeline

8 February 2019

Primary endpoint
7 March 2022

7 January 2025

Quick facts

Lead sponsor	Janssen-Cilag International NV
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	880
Start date	8 February 2019
Primary completion	7 March 2022
Estimated completion	7 January 2025
Sites	90 locations across France, Germany

Drugs / interventions tested

Guselkumab (GUSELKUMAB) — full drug profile →
Placebo Injection

Conditions studied

Psoriasis — all drugs for Psoriasis →

Sponsor

Janssen-Cilag International NV — full company profile →

Who can join

18 and older, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68 Primary · Week 68

Percentage of participants who achieved an absolute PASI \<3 at Week 68 were reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the body surface area involved, which translates to a numeric score that ranged from 0 (indicated no involvement) to 6 (90 percent \[%\]-100% involvement), and for erythema, induration and scaling, which are each rat

Group	Value	95% CI
Part 2 Group 2a: Guselkumab 100 mg Q8W	92.6	88.0 – 95.8
Part 2 Group 2b: Guselkumab 100 mg Q16W	91.9	87.3 – 95.3

Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score Secondary · Group 1: Week 0 up to Week 28; Group 2c: Week 28 up to Week 68

Time to improvement from baseline in PASI 75/90/100 response for participants with short disease duration (SDD) and longer disease duration (LDD) was reported. PASI was used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, which were each rated on

PASI 75

Group	Value	95% CI
Part 1 Group 1: Participants With Disease Duration <= 2 Years	84.0	81.0 – 89.0
Part 1 Group 1: Participants With Disease Duration > 2 Years	84.0	81.0 – 90.0
Part 2 Group 2c: Participants With Disease Duration <= 2 Years	84.0	83.0 – 112.0
Part 2 Group 2c: Participants With Duration > 2 Years	84.0	83.0 – 105.0

PASI 90

Group	Value	95% CI
Part 1 Group 1: Participants With Disease Duration <= 2 Years	89.0	84.0 – 134.0
Part 1 Group 1: Participants With Disease Duration > 2 Years	106.0	84.0 – 140.0
Part 2 Group 2c: Participants With Disease Duration <= 2 Years	112.0	84.0 – 153.0
Part 2 Group 2c: Participants With Duration > 2 Years	114.0	84.0 – 196.0

PASI 100

Group	Value	95% CI
Part 1 Group 1: Participants With Disease Duration <= 2 Years	141.0	105.0 – 210.0
Part 1 Group 1: Participants With Disease Duration > 2 Years	200.0	113.0 – NA
Part 2 Group 2c: Participants With Disease Duration <= 2 Years	308.0	196.0 – 483.0
Part 2 Group 2c: Participants With Duration > 2 Years	416.0	198 – NA

Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220 Secondary · Group 1: Weeks 20 and 28; Groups 2a, 2b, 2c: Week 68; Groups 3a and 3b: Weeks 116, 164 and 220

Percentage of participants with short (\<=2 years) and longer (\>2 years) disease duration who achieved an absolute PASI Score of 0, \<=1 and less than (\<) 3 was reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and

PASI = 0 (Week 20)

Group	Value	95% CI
Part 1 Group 1: Participants With Disease Duration <= 2 Years	49.3
Part 1 Group 1: Participants With Disease Duration > 2 Years	32.7

PASI <=1 (Week 20)

Group	Value	95% CI
Part 1 Group 1: Participants With Disease Duration <= 2 Years	67.8
Part 1 Group 1: Participants With Disease Duration > 2 Years	54.3

PASI <3 (Week 20)

Group	Value	95% CI
Part 1 Group 1: Participants With Disease Duration <= 2 Years	85.2
Part 1 Group 1: Participants With Disease Duration > 2 Years	82.4

PASI = 0 ( Week 28)

Group	Value	95% CI
Part 1 Group 1: Participants With Disease Duration <= 2 Years	51.8
Part 1 Group 1: Participants With Disease Duration > 2 Years	39.4

PASI <=1 (Week 28)

Group	Value	95% CI
Part 1 Group 1: Participants With Disease Duration <= 2 Years	70.3
Part 1 Group 1: Participants With Disease Duration > 2 Years	59.5

PASI <3 (Week 28)

Group	Value	95% CI
Part 1 Group 1: Participants With Disease Duration <= 2 Years	86.8
Part 1 Group 1: Participants With Disease Duration > 2 Years	83.9

PASI = 0 (Week 68)

Group	Value	95% CI
Part 2 Group 2a: Participants With Disease Duration <= 2 Years	81.3
Part 2 Group 2a: Participants With Disease Duration > 2 Years	80.8
Part 2 Group 2b: Participants With Disease Duration <= 2 Years	73.7
Part 2 Group 2b: Participants With Disease Duration > 2 Years	64.4
Part 2 Group 2c: Participants With Disease Duration <= 2 Years	39.9
Part 2 Group 2c: Participants With Disease Duration > 2 Years	37.2

PASI <=1 (Week 68)

Group	Value	95% CI
Part 2 Group 2a: Participants With Disease Duration <= 2 Years	86.7
Part 2 Group 2a: Participants With Disease Duration > 2 Years	93.2
Part 2 Group 2b: Participants With Disease Duration <= 2 Years	81.6
Part 2 Group 2b: Participants With Disease Duration > 2 Years	76.7
Part 2 Group 2c: Participants With Disease Duration <= 2 Years	73.6
Part 2 Group 2c: Participants With Disease Duration > 2 Years	55.9

Group 3a and Group 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Retain Disease Control (Absolute PASI Score < 3) Secondary · From Week 68 up to Week 220

Percentage of participants who retain disease control (that is, absolute PASI score \<3 from Week 68 through Week 220 for participants with short (\<= 2 years) and longer (\>2 years) disease duration was reported. Control of disease was defined as participants with a PASI score \<3. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric scor

Group	Value	95% CI
Part 3 Group 3a: Participants With Disease Duration <=2 Years	7.5	2.5 – 16.6
Part 3 Group 3a: Participants With Disease Duration> 2 Years	0.0	0.0 – 5.2
Part 3 Group 3b: Participants With Disease Duration <= 2 Years	2.8	0.3 – 9.8
Part 3 Group 3b: Participants With Disease Duration > 2 Years	1.5	0.0 – 8.2

Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220 Secondary · Group 1: Weeks 20, 28; Groups 2a, 2b, 2c: Week 68; Groups 3a, 3b: Weeks 116, 164 and 220

Percentage of participants who achieved PASI 75/90/100 response were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could

PASI 75 (Week 20)

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	90.2

PASI 75 (Week 28)

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	90.7

PASI 90 (Week 20)

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	73.6

PASI 90 (Week 28)

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	76.0

PASI 100 (Week 20)

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	39.4

PASI 100 (Week 28)

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	44.4

PASI 75 (Week 68)

Group	Value	95% CI
Part 2 Group 2a: Guselkumab 100 mg Q8W	92.6
Part 2 Group 2b: Guselkumab 100 mg Q16W	94.0
Part 2 Group 2c: Guselkumab 100 mg Q8W	88.0

PASI 90 (Week 68)

Group	Value	95% CI
Part 2 Group 2a: Guselkumab 100 mg Q8W	91.9
Part 2 Group 2b: Guselkumab 100 mg Q16W	85.9
Part 2 Group 2c: Guselkumab 100 mg Q8W	73.7

Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score >5) After Treatment Withdrawal Secondary · From Week 68 up to Week 220

Time to loss of disease control (absolute PASI score \>5) after treatment withdrawal beyond Week 68 up to Week 220 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale o

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	245	203 – 286
Part 3 Group 3b: Withdrawal (Q16W)	189	166 – 251

Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28 Secondary · Weeks 12, 16, 20 and 28

Percentage of participants with an absolute PASI score = 0 at Weeks 12, 16, 20 and 28 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a num

Week 12

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100 mg	17.8

Week 16

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100 mg	29.0

Week 20

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100 mg	39.4

Week 28

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100 mg	44.4

Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score Secondary · Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b:Baseline (Week 0), Week 116, 164 and 220; Group 3c: Baseline (Re-Treatment [R] Week 0), Week R24

Change from baseline (Week 0) in DLQI score were reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

Week 28

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	-16.6	± 6.2

Week 68

Group	Value	95% CI
Part 2 Group 2a: Guselkumab 100 mg Q8W	-18.8	± 5.6
Part 2 Group 2b: Guselkumab 100 mg Q16W	-17.0	± 5.5
Part 2 Group 2c: Guselkumab 100 mg Q8W	-17.1	± 5.8

Week 116

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-16.5	± 6.3
Part 3 Group 3b: Withdrawal (Q16W)	-15.5	± 6.4

Week 164

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-18.1	± 6.7
Part 3 Group 3b: Withdrawal (Q16W)	-17.4	± 7.8

Week 220

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-20.9	± 6.0
Part 3 Group 3b: Withdrawal (Q16W)	-16.3	± 6.5

Re-Treatment till R24 weeks

Group	Value	95% CI
Part 3 Group 3c: Re-Treatment Guselkumab 100mg	-10.1	± 6.8

Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5 Secondary · Group 1: Week 28; Groups 2a, 2b, 2c: Week 68; Groups 3a and 3b: Week 116, 164 and 220; Group 3c: Week R24

Percentage of participants who achieved a DLQI score 0/1 and \<5 was reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

DLQI Score 0/1 (Week 28)

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	60.9

DLQI Score<5 (Week 28)

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	78.4

DLQI Score 0/1 (Week 68)

Group	Value	95% CI
Part 2 Group 2a: Guselkumab 100 mg Q8W	83.1
Part 2 Group 2b: Guselkumab 100 mg Q16W	77.9
Part 2 Group 2c: Guselkumab 100 mg Q8W	61.9

DLQI Score<5 (Week 68)

Group	Value	95% CI
Part 2 Group 2a: Guselkumab 100 mg Q8W	89.2
Part 2 Group 2b: Guselkumab 100 mg Q16W	85.2
Part 2 Group 2c: Guselkumab 100 mg Q8W	78.9

DLQI Score 0/1 (Week 116)

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	15.4
Part 3 Group 3b: Withdrawal (Q16W)	10.9

DLQI Score <5 (Week 116)

Group	Value	95% CI
Part 3 Group 3a: Participants With Disease Duration <=2 Years	34.3
Part 3 Group 3a: Participants With Disease Duration> 2 Years	15.9
Part 3 Group 3b: Participants With Disease Duration <= 2 Years	26.8
Part 3 Group 3b: Participants With Disease Duration > 2 Years	7.6

DLQI Score 0/1 (Week 164)

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	8.1
Part 3 Group 3b: Withdrawal (Q16W)	5.8

DLQI Score <5 (Week 164)

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	8.1
Part 3 Group 3b: Withdrawal (Q16W)	8.0

Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA) Secondary · Group 1: Baseline (Week 0), Week 12, 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 52 and 68, Group 3a, 3b: Baseline (Week 0), Week 80, 104, 116, 140, 164, 188, 212 and 220

Percent change from baseline in the psoriasis affected BSA (%) was reported. The percentage of the psoriasis-affected BSA percentage is a system used for assessing the severity of psoriasis. The plaque coverage is estimated using the rule of palm (1 palm of the hand = 1% BSA)

At Week 12

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	-19.3	± 14.2

At Week 28

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	-23.8	± 15.0

At Week 52

Group	Value	95% CI
Part 2 Group 2a: Guselkumab 100 mg Q8W	-25.1	± 15.1
Part 2 Group 2b: Guselkumab 100 mg Q16W	-24.3	± 15.6
Part 2 Group 2c: Guselkumab 100 mg Q8W	-24.8	± 14.6

At Week 68

Group	Value	95% CI
Part 2 Group 2a: Guselkumab 100 mg Q8W	-24.8	± 14.9
Part 2 Group 2b: Guselkumab 100 mg Q16W	-24.3	± 15.8
Part 2 Group 2c: Guselkumab 100 mg Q8W	-25.0	± 14.6

At Week 80

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-23.8	± 14.1
Part 3 Group 3b: Withdrawal (Q16W)	-23.6	± 15.6

At Week 104

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-20.6	± 15.1
Part 3 Group 3b: Withdrawal (Q16W)	-22.5	± 16.8

At Week 116

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-22.4	± 16.8
Part 3 Group 3b: Withdrawal (Q16W)	-19.8	± 13.0

At Week 140

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-16.7	± 8.5
Part 3 Group 3b: Withdrawal (Q16W)	-19.6	± 11.2

Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220 Secondary · Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b: Baseline (Week 0), Week 116, 164, and 220

Change from baseline in NAPPA-CLIN at Weeks 28, 68, 116 164, and 220 was reported. NAPPA-CLIN is an instrument used by the physician to assess the least and the worst involved nail of both hands or both feet with scores ranging from 0 (no involvement) to 16 (worst involvement). A higher score indicated a worst involvement.

Hands (Week 28)

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	-3.4	± 3.2

Feet (Week 28)

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	-3.1	± 3.5

Hands (Week 68)

Group	Value	95% CI
Part 2 Group 2a: Guselkumab 100 mg Q8W	-4.0	± 3.2
Part 2 Group 2b: Guselkumab 100 mg Q16W	-4.5	± 3.5
Part 2 Group 2c: Guselkumab 100 mg Q8W	-4.0	± 3.2

Feet (Week 68)

Group	Value	95% CI
Part 2 Group 2a: Guselkumab 100 mg Q8W	-4.9	± 3.5
Part 2 Group 2b: Guselkumab 100 mg Q16W	-4.6	± 3.7
Part 2 Group 2c: Guselkumab 100 mg Q8W	-4.1	± 3.6

Hands (Week 116)

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-2.2	± 4.3
Part 3 Group 3b: Withdrawal (Q16W)	-2.2	± 3.2

Feet (Week 116)

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-3.4	± 6.2
Part 3 Group 3b: Withdrawal (Q16W)	-3.5	± 3.9

Hands (Week 164)

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-4.5	± 3.5
Part 3 Group 3b: Withdrawal (Q16W)	-3.0	± 2.4

Feet (Week 164)

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-8.0	± NA
Part 3 Group 3b: Withdrawal (Q16W)	-3.6	± 3.1

Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220 Secondary · Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b: Baseline (Week 0), Week 116, 164, and 220

Change from baseline (Week 0) in the signs and symptoms aggregate scores of the PSSD at Weeks 28, 68, 116, 164 and 220 was reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores ea

At Week 28 (Symptom)

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	-57.2	± 25.4

At Week 28 (Sign)

Group	Value	95% CI
Part 1 Group 1: Guselkumab 100mg	-62.1	± 22.0

At Week 68 (Symptom)

Group	Value	95% CI
Part 2 Group 2a: Guselkumab 100 mg Q8W	-65.1	± 21.2
Part 2 Group 2b: Guselkumab 100 mg Q16W	-58.7	± 23.3
Part 2 Group 2c: Guselkumab 100 mg Q8W	-58.6	± 25.1

At Week 68 (Sign)

Group	Value	95% CI
Part 2 Group 2a: Guselkumab 100 mg Q8W	-71.7	± 16.4
Part 2 Group 2b: Guselkumab 100 mg Q16W	-65.4	± 19.6
Part 2 Group 2c: Guselkumab 100 mg Q8W	-63.0	± 22.2

At Week 116 (Symptom)

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-52.3	± 25.7
Part 3 Group 3b: Withdrawal (Q16W)	-50.0	± 24.3

At Week 116 (Sign)

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-56.1	± 25.6
Part 3 Group 3b: Withdrawal (Q16W)	-52.2	± 24.3

At Week 164 (Symptom)

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-59.7	± 20.5
Part 3 Group 3b: Withdrawal (Q16W)	-54.0	± 26.1

At Week 164 (Sign)

Group	Value	95% CI
Part 3 Group 3a: Withdrawal (Q8W)	-62.1	± 22.0
Part 3 Group 3b: Withdrawal (Q16W)	-50.4	± 26.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1 Group 1: Guselkumab 100mg

Serious: 38/880 (4%)

Deaths: 1/880

Group 2a: Guselkumab 100 mg Q8W

Serious: 7/148 (5%)

Deaths: 0/148

Group 2b: Guselkumab 100 mg Q16W

Serious: 6/149 (4%)

Deaths: 0/150

Group 2c: Guselkumab 100 mg Q8W

Serious: 33/525 (6%)

Deaths: 1/525

Part 2 Group 2d: Re-Treatment Guselkumab 100mg

Serious: 0/9 (0%)

Deaths: 0/9

Group 3a Guselkumab 100 mg Q8W

Serious: 3/136 (2%)

Deaths: 0/136

Group 3b Guselkumab 100 mg Q16W

Serious: 9/137 (7%)

Deaths: 0/137

Group 3c Guselkumab 100 mg

Serious: 8/227 (4%)

Deaths: 0/227

Serious adverse events (94 terms)

Reaction	System	Part 1 Group 1: Guselkumab…	Group 2a: Guselkumab 100 m…	Group 2b: Guselkumab 100 m…	Group 2c: Guselkumab 100 m…	Part 2 Group 2d: Re-Treatm…	Group 3a Guselkumab 100 mg…	Group 3b Guselkumab 100 mg…	Group 3c Guselkumab 100 mg
Acute Myocardial Infarction	Cardiac disorders	—	—	—	—	—	—	—	—
Myocardial Infarction	Cardiac disorders	—	—	—	—	—	—	—	—
Ligament Rupture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—	—	—	—	—
Psoriasis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Splenic Haematoma	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Acute Coronary Syndrome	Cardiac disorders	—	—	—	—	—	—	—	—
Arteriosclerosis Coronary Artery	Cardiac disorders	—	—	—	—	—	—	—	—
Cardiac Failure Chronic	Cardiac disorders	—	—	—	—	—	—	—	—
Coronary Artery Disease	Cardiac disorders	—	—	—	—	—	—	—	—
Myocarditis	Cardiac disorders	—	—	—	—	—	—	—	—
Abdominal Hernia	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Colitis Ischaemic	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Hiatus Hernia	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Chest Pain	General disorders	—	—	—	—	—	—	—	—
Cholecystitis Chronic	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Cholestasis	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Anaphylactic Reaction	Immune system disorders	—	—	—	—	—	—	—	—
Autoimmune Disorder	Immune system disorders	—	—	—	—	—	—	—	—
Hypersensitivity	Immune system disorders	—	—	—	—	—	—	—	—
Abscess of External Auditory Meatus	Infections and infestations	—	—	—	—	—	—	—	—

Other adverse events (652 terms — click to expand)

Reaction	System	Part 1 Group 1: Guselkumab…	Group 2a: Guselkumab 100 m…	Group 2b: Guselkumab 100 m…	Group 2c: Guselkumab 100 m…	Part 2 Group 2d: Re-Treatm…	Group 3a Guselkumab 100 mg…	Group 3b Guselkumab 100 mg…	Group 3c Guselkumab 100 mg
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—
Covid-19	Infections and infestations	—	—	—	—	—	—	—	—
Blood Creatine Phosphokinase Increased	Investigations	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—
Psoriasis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—
Inappropriate Schedule of Product Administration	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—
Gastrointestinal Infection	Infections and infestations	—	—	—	—	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—	—	—	—	—
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Blood Triglycerides Increased	Investigations	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Intertrigo	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Abdominal Pain Upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—	—	—
Gamma-Glutamyltransferase Increased	Investigations	—	—	—	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Injection Site Erythema	General disorders	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—
Oral Herpes	Infections and infestations	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—
Folliculitis	Infections and infestations	—	—	—	—	—	—	—	—
Alanine Aminotransferase Increased	Investigations	—	—	—	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Chest Pain	General disorders	—	—	—	—	—	—	—	—
Oedema Peripheral	General disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Acute Myocardial Infarction, Myocardial Infarction, Ligament Rupture, Intervertebral Disc Protrusion, Depression, Psoriasis, Splenic Haematoma, Acute Coronary Syndrome.

Data from ClinicalTrials.gov NCT03818035 adverse events section.

Sponsor's own description

The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis participants who receive on-label guselkumab treatment until week 20 and respond with a Psoriasis Area and Severity Index score (PASI) = 0 at weeks 20 and 28) maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every 16 weeks).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
Sbidian E, Chaimani A, Garcia-Doval I, Doney L, et al · · 2022 · cited 84× · PMID 35603936 · DOI 10.1002/14651858.cd011535.pub5
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
Sbidian E, Chaimani A, Guelimi R, Garcia-Doval I, et al · · 2023 · cited 67× · PMID 37436070 · DOI 10.1002/14651858.cd011535.pub6
IL-23 blockade with guselkumab potentially modifies psoriasis pathogenesis: rationale and study protocol of a phase 3b, randomised, double-blind, multicentre study in participants with moderate-to-severe plaque-type psoriasis (GUIDE).
Eyerich K, Weisenseel P, Pinter A, Schäkel K, et al · · 2021 · cited 58× · PMID 34518264 · DOI 10.1136/bmjopen-2021-049822
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
Sbidian E, Chaimani A, Garcia-Doval I, Doney L, et al · · 2021 · cited 54× · PMID 33871055 · DOI 10.1002/14651858.cd011535.pub4
Noninferiority of 16-Week vs 8-Week Guselkumab Dosing in Super Responders for Maintaining Control of Psoriasis: The GUIDE Randomized Clinical Trial.
Eyerich K, Asadullah K, Pinter A, Weisenseel P, et al · · 2024 · cited 22× · PMID 39083288 · DOI 10.1001/jamadermatol.2024.2463
Predictive Factors for Super Responder Status and Long-Term Effectiveness of Guselkumab in Psoriasis: A Multicenter Retrospective Study.
Mortato E, Talamonti M, Marcelli L, Megna M, et al · · 2025 · cited 8× · PMID 40238056 · DOI 10.1007/s13555-025-01394-2
Characterization of Super-Responder Profile in Chronic Plaque Psoriatic Patients under Guselkumab Treatment: A Long-Term Real-Life Experience.
Marcelli L, Belcastro A, Talamonti M, Paganini C, et al · · 2024 · cited 8× · PMID 39274388 · DOI 10.3390/jcm13175175
Early intervention in psoriasis: Where do we go from here?
Felix PAO, Sampaio AL, Silva BL, Viana ALP. · · 2022 · cited 7× · PMID 36530901 · DOI 10.3389/fmed.2022.1027347

Verify or expand the search:

Other trials of Guselkumab

Trials testing the same drug.

NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
NCT07528040 — An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With C · not yet recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
NCT06916390 — GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis · Phase 4 · not yet recruiting
NCT07141004 — A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA) · Phase 4 · recruiting

Other recruiting trials for Psoriasis

Currently open trials in the same condition.

NCT07471048 — A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoria · NA · recruiting
NCT07449234 — A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis · recruiting
NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO) · recruiting
NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial · Phase 2 · recruiting
NCT07250997 — PALLAS Laser for Skin Diseases · NA · recruiting

Other Janssen-Cilag International NV trials

Trials by the same sponsor.

NCT04940039 — A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings · Phase 4 · completed
NCT04338321 — A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selectiv · Phase 3 · completed
NCT03852160 — A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Stan · Phase 3 · withdrawn
NCT03947814 — A Study of Orally Administered Pimodivir in Adult Participants With Renal Impairment · Phase 1 · terminated
NCT03816631 — A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03818035 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen-Cilag International NV
Last refreshed: 23 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03818035.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing