Phase 3
Completed N=119
A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT02951533 ↗Enrolled (actual)
119
Serious AEs
4.3%
Results posted
Feb 2019
Primary outcomePrimary: Part I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24 — 81.7; 13.6 Percentage of Participants — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to compare the efficacy of Guselkumab with commercially available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants with moderate to severe plaque-type psoriasis who have not yet received any systemic therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24 |
81.7; 13.6 | <0.0001 sig |
| SECONDARY Part I: Percentage of Participants Who Achieved PASI 75 Response at Week 24 |
90.0; 27.1 | — |
| SECONDARY Part I: Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of Less Than or Equal to (=<) 1 at Week 24 |
61.7; 16.9 | — |
| SECONDARY Part I: Percentage of Participants Who Achieved PASI 100 Response at Week 24 |
31.7; 3.4 | — |
| SECONDARY Part I: Change From Baseline in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) Score at Week 24 |
-59.8; -39.7; -52.0; -34.0 | — |
| SECONDARY Part I: Change From Baseline in the Individual Scale Scores for Itch, Pain, and Scaling of PSSD Components at Week 24 |
-5.85; -3.90; -5.07; -2.93; -6.48; -4.43 | — |
| SECONDARY Part I: Percentage of Participants Who Achieved an Absolute PASI Score Less Than or Equal to (=<) 1 at Week 24 |
66.7; 10.2 | — |
| SECONDARY Part I: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score 0 at Week 24 |
51.7; 6.8 | — |
| SECONDARY Part I: Change From Baseline in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 24 |
-18.5; -9.2 | — |
| SECONDARY Part I: Change From Baseline in DLQI Score at Week 24 |
-15.2; -9.4 | — |
| SECONDARY Part I: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of Absence of Disease (0) at Week 24 |
48.1; 13.2 | — |
| SECONDARY Part I: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 24 |
8.0; 2.3; 5.8; 6.5 | — |
| SECONDARY Part IIb: Percentage of Participants With a PASI 75 Response at Week 32 Who Maintained Response at Week 56 |
98.1; 64.3 | — |
| SECONDARY Part IIb: Percentage of Participants With a PASI 90 Response at Week 32 Who Maintained Response at Week 56 |
85.2; 35.7 | — |
| SECONDARY Part IIb: Percentage of Participants With DLQI Score of 0 or 1 at Week 32 Who Maintained Response at Week 56 |
64.8; 21.4 | — |
| SECONDARY Part IIb: Percentage of Participants With a PASI 75 Response at Week 56 |
98.1; 64.3 | — |
| SECONDARY Part IIb: Percentage of Participants With a PASI 90 Response at Week 56 |
90.7; 50.0 | — |
| SECONDARY Part IIb: Percentage of Participants With a PASI 100 Response at Week 56 |
53.7; 21.4 | — |
| SECONDARY Part IIb: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56 |
72.2; 28.6 | — |
| SECONDARY Part I/IIa: Percentage of Participants Who Achieved PASI 75 Response at Week 32 |
90.0; 23.7 | — |
| SECONDARY Part I/IIa: Percentage of Participants Who Achieved PASI 90 Response at Week 32 |
78.3; 11.9 | — |
| SECONDARY Part I/IIa: Percentage of Participants Who Achieved PASI 100 Response at Week 32 |
43.3; 6.8 | — |
| SECONDARY Part I/IIa: Percentage of Participants With a DLQI Score of 0 or 1 at Week 32 |
63.3; 16.9 | — |
| SECONDARY Part III: Percentage of Participants With a PASI 90 Response at Week 56 Who Maintained Response (That is Who Had PASI Score <=5) at Week 100 After Drug Withdrawal |
47.2; 25.0 | — |
| SECONDARY Part III: Time to Loss of Response (PASI >5) From Week 56 After Guselkumab Withdrawal at Week 100 |
315; 293 | — |
| SECONDARY Part III: Time to PASI >3 From Week 56 After Guselkumab Withdrawal at Week 100 |
306; 226 | — |
| SECONDARY Part III: Time to Loss of Response (PASI >5) From Week 52 After Guselkumab Withdrawal at Week 100 |
336; 321 | — |
| SECONDARY Part III: Time to PASI >3 From Week 52 After Guselkumab Withdrawal at Week 100 |
334; 254 | — |
| SECONDARY Part III: Percentage of Participants With PASI 90 Response at Week 56 Who Maintained PASI 90 Response at Week 100 After Drug Withdrawal |
13.9; 8.3 | — |
| SECONDARY Part III: Percentage of Participants Who Achieved PASI 100 Response at Week 100 |
5.6; 0.0 | — |
| SECONDARY Part III: Percentage of Participants Who Achieved an Absolute PASI Score <=1, <=2, <=3, <=5 at Week 100 |
8.3; 0.0; 19.4; 8.3; 30.6; 16.7 | — |
| SECONDARY Part III: Change From Baseline (Week 56) in Signs and Symptoms Aggregate Scores of the Psoriasis Symptom and Sign Diary (PSSD) Total Score at Week 100 |
3.4; 11.2; 25.1; 30.7; 5.4; 13.5 | — |
| SECONDARY Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 at Week 100 |
8.3; 0.0 | — |
| SECONDARY Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 at Week 100 |
30.6; 16.7 | — |
| SECONDARY Part III: Change From Baseline (Week 56) in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 100 |
0.9; 1.5; 6.1; 9.1 | — |
| SECONDARY Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 100 |
25; 8.3 | — |
| SECONDARY Part III: Change From Baseline in DLQI Score at Week 100 |
0.9; 3.5; 5.3; 8.0 | — |
| SECONDARY Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56 Who Maintained Response at Week 100 |
25; 8.3 | — |
| SECONDARY Part III: Percentage of Participants Who Achieved Ss-IGA Score of Absence of Disease (0) at Week 100 in Participants With Scalp Psoriasis and Ss-IGA Score>=2 (at Least Mild Disease) at Baseline (Week 0) |
14.7; 8.3 | — |
| SECONDARY Part III: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of 0 or 1 at Week 100 in Participants With Scalp Psoriasis and an Ss-IGA Score >=2 (at Least Mild Disease) at Baseline (Week 0) |
32.4; 25.0 | — |
| SECONDARY Part III: Change From Baseline (Week 56) in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 100 |
57.8; 54.9; -4.3; -3.7; 53.4; 44.2 | — |
| SECONDARY Part I/IIa: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (up to Week 32) as a Measure of Safety and Tolerability |
78.3; 98.3 | — |
| SECONDARY Part IIb: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (Week 32 to Week 64) as a Measure of Safety and Tolerability |
79.6; 92.9; 0; 70.0 | — |
| SECONDARY Part III: Percentage of Participants With Adverse Drug Reactions (ADRs) as a Measure of Safety and Tolerability |
5.6; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of plaque-type psoriasis for at least 6 months before the first administration of study drug
- Have a Psoriasis Area and Severity Index (PASI) greater than (>)10 or Body Surface Area (BSA) >10 at screening and at baseline
- Have a Dermatology Life Quality Index (DLQI) >10 at screening and at baseline
- Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug; for information on Bacille Calmette-Guérin (BCG) vaccination, agree not to receive a BCG vaccination during the study, or within 12 months after the last administration of study drug
- No dipstick detection of proteins or glucose in urine. If there are signs of proteins and/or glucose on urine test strip, the urine sample must be analyzed centrally. Here, protein and glucose levels must not exceed trace levels, example, <=(+); one re-test (central urine analysis) is allowed
Exclusion Criteria
- Has a history or current signs or symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- Known allergies, hypersensitivity, or intolerance to Guselkumab or its excipients
- Is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 12 weeks after the last dose of study drug
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Data sourced from ClinicalTrials.gov (NCT02951533). 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. Informational only — not medical advice.