Phase 3
N=880
A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT03818035 ↗Enrolled (actual)
880
Serious AEs
4.7%
Results posted
May 2023
Primary outcome: Primary: 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 — 92.6; 91.9 Percentage of participants — p=0.0013
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Guselkumab (Drug); Placebo Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen-Cilag International NV
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
92.6; 91.9 | 0.0013 sig |
| SECONDARY Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score |
84.0; 84.0; 84.0; 84.0; 89.0; 106.0 | — |
| SECONDARY 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 |
49.3; 32.7; 67.8; 54.3; 85.2; 82.4 | — |
| SECONDARY 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) |
7.5; 0.0; 2.8; 1.5 | — |
| SECONDARY 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 |
90.2; 90.7; 73.6; 76.0; 39.4; 44.4 | — |
| SECONDARY Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score >5) After Treatment Withdrawal |
245; 189 | — |
| SECONDARY Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28 |
17.8; 29.0; 39.4; 44.4 | — |
| SECONDARY Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score |
-16.6; -18.8; -17.0; -17.1; -16.5; -15.5 | — |
| SECONDARY Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5 |
60.9; 78.4; 83.1; 77.9; 61.9; 89.2 | — |
| SECONDARY Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA) |
-19.3; -23.8; -25.1; -24.3; -24.8; -24.8 | — |
| SECONDARY 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 |
-3.4; -3.1; -4.0; -4.5; -4.0; -4.9 | — |
| SECONDARY 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 |
-57.2; -62.1; -65.1; -58.7; -58.6; -71.7 | — |
| SECONDARY Groups 2a, 2b and 2c: Percentage of Participants Who Achieved a PSSD Sign Score = 0 at Week 68 in Participants With a PSSD Sign Score >= 1 at Week 28 |
30.2; 21.7; 14.8 | — |
| SECONDARY Groups 2a and 2b: Serum Trough Guselkumab Levels at Weeks 20, 28, 36 and 68 |
1.61; 1.60; 1.58; 1.67; 1.68; 0.38 | — |
| SECONDARY Groups 2d and 3c: Percentage of Participants Who Were Re-Treated Due to Loss of Disease Control (PASI >5) and Regain Control of Disease (PASI <3) 24 Weeks After Start of Re-Treatment |
88.8; 98.2 | — |
| SECONDARY Groups 1, 2a, 2b, 2c, 2d,3a, 3b, and 3c: Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability |
74.8; 68.9; 69.8; 72.0; 55.1; 55.5 | — |
| SECONDARY Groups 1, 2a, 2b, 2c, 2d, 3a,3b and 3c: Number of Participants With Clinically Significant Laboratory Abnormalities |
2; 1; 0; 1; 0; 1 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Has a disease duration of plaque psoriasis of either less than or equal to ( 2) years calculated from date at which first symptoms [plaque] were reported by subject to date of screening visit at screening; approximately 40 percentage (%) of participants must have a disease duration 10 or affected body surface area (BSA) >10%) and additionally a Dermatology Life Quality Index (DLQI) score >10 at baseline (week 0)
- Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination
- Agrees not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
- Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
Exclusion Criteria
- Has previously received any therapeutic agent directly targeted to interleukin (IL) -23 (including but not limited to guselkumab, tildrakizumab [MK3222], risankizumab [BI-655066])
- Has received any systemic immunosuppressant (for example, methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus, fumaric acid esters), or anakinra within 4 weeks of the first administration of study drug.
- Tests positive for hepatitis B virus (HBV) infection or who are seropositive for antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative HCV RNA test result at baseline
- Has received natalizumab, belimumab, or agents that modulate B cells or T cells (e.g., rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first administration of study drug
- Has received any anti - tumor necrosis factor (TNF)-α biologic therapy within 3 months before the first administration of study drug
Data sourced from ClinicalTrials.gov (NCT03818035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.