Phase 3
Completed N=1,048
A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
Source: ClinicalTrials.gov NCT03090100 ↗Enrolled (actual)
1,048
Serious AEs
6.7%
Results posted
Oct 2019
Primary outcomePrimary: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 — 84.5; 70.0 Percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
372citations · ~53 / year
Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial.
Summary
The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.
Linked Publications (4)
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Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial.
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Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis.
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Differential Pharmacodynamic Effects on Psoriatic Biomarkers by Guselkumab Versus Secukinumab Correlate with Long-Term Efficacy: An ECLIPSE Substudy.
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Response Types and Factors Associated with Response Types to Biologic Therapies in Patients with Moderate-to-Severe Plaque Psoriasis from Two Randomized Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 |
84.5; 70.0 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48 |
84.6; 80.2 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved a PASI-90 Response at Week 12 |
69.1; 76.1 | — |
| SECONDARY Percentage of Participants Who Achieved a PASI-75 Response at Week 12 |
89.3; 91.6 | — |
| SECONDARY Percentage of Participants Who Achieved a PASI-100 Response at Week 48 |
58.2; 48.4 | — |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48 |
62.2; 50.4 | — |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48 |
85.0; 74.9 | — |
| SECONDARY Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48 |
72.3; 64.4 | — |
| SECONDARY Percentage of Participants Who Achieved a PASI-75 Response at Week 16 |
92.7; 92.8 | — |
| SECONDARY Percentage of Participants Who Achieved a PASI-90 Response at Week 16 |
78.5; 79.6 | — |
| SECONDARY Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48 |
71.0; 61.5 | — |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16 |
86.7; 86.6 | — |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12 |
85.6; 86.4 | — |
| SECONDARY Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12 |
94.8; 87.5 | — |
| SECONDARY Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16 |
92.1; 80.9 | — |
| SECONDARY Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 |
0; 0; 0; 0; 2.1; 1.8 | — |
| SECONDARY Percentage of Participants With IGA Responses Through Week 56 |
0; 0; 3.4; 2.5; 27.2; 34.2 | — |
| SECONDARY Percent Improvement From Baseline in PASI Through Week 56 |
20.30; 24.72; 37.85; 44.56; 52.76; 60.57 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis]PsA) for at least 6 months before the first administration of study drug
- A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections
- 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
- Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
- Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study
Exclusion Criteria
- Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has previously received guselkumab or secukinumab
- Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
- Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
- Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
Data sourced from ClinicalTrials.gov (NCT03090100) and the linked publication. 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.