Phase 3
Completed N=78
Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
Source: ClinicalTrials.gov NCT02905331 ↗Enrolled (actual)
78
Serious AEs
3.3%
Results posted
Sep 2018
Primary outcomePrimary: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 — 0; 80.6 Percentage of participants — p=<0.001
◆ Published Evidence
Established
55citations · ~9 / year
Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study.
Summary
The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.
Linked Publications (2)
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Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 |
0; 80.6 | <0.001 sig |
| PRIMARY Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 |
0; 75.8 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieve an IGA Score of Cleared (0) at Week 16 |
0; 56.5 | — |
| SECONDARY Percentage of Participants Who Achieve a PASI 100 Response at Week 16 |
0; 50.0 | — |
| SECONDARY Percentage of Participants Who Achieved an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 16 |
0; 93.5 | — |
| SECONDARY Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16 |
0; 93.5; 0; 88.7 | — |
| SECONDARY Percent Improvement From Baseline in PASI Score at Week 16 |
8.72; 91.53 | <0.001 sig |
| SECONDARY Percent Improvement From Baseline in PASI Score Through Week 40 |
5.58; 40.99; 10.45; 71.76; 13.76; 84.97 | — |
| SECONDARY Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 |
0; 4.8; 0; 19.4; 0; 54.8 | — |
| SECONDARY Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses |
0; 3.2; 0; 4.8; 0; 12.9 | — |
Eligibility Criteria
Inclusion Criteria
- A woman of childbearing potential must have a negative urine pregnancy test (beta-human chorionic gonadotropin) at screening and at Week 0
- Before randomization, a woman must be either: a) Not of childbearing potential: premenarchal; postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle-stimulating hormone level (FSH) >40 International Units Per Liter [IU/L]); permanently sterile (example, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy, b) Of childbearing potential and practicing a highly effective method of birth control, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/ film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant)
- Agree not to receive a Bacillus Calmette Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
- Have a Psoriasis Area and Severity Index (PASI) greater than or equal to [>=] 12 at screening and at baseline
- Have an involved body surface area (BSA) >= 10 percent (%) at screening and at baseline
Exclusion Criteria
- Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
- Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
- Has a transplanted organ (with exception of a corneal transplant >3 months before the first administration of study drug)
- Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
- Has received any anti-tumor necrosis factor alpha (TNF-alpha) biologic therapy within 3 months before the first administration of study drug
Data sourced from ClinicalTrials.gov (NCT02905331) 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.