Phase 3
N=192
An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02325219 ↗Enrolled (actual)
192
Serious AEs
6.8%
Results posted
May 2020
Primary outcome: Primary: Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 — 7.8; 92.3; 88.9 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CNTO 1959 50 mg (Drug); CTNO 1959 100 mg (Drug); Placebo 50 mg (Drug); Placebo 100 mg (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Janssen Pharmaceutical K.K.
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 |
7.8; 92.3; 88.9 | <0.001 sig |
| PRIMARY Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 |
0; 70.8; 69.8 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved PASI 75 Response at Week 16 |
6.3; 89.2; 84.1 | — |
| SECONDARY Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 |
-0.8; -8.3; -8.5 | — |
| SECONDARY Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16 |
0; 0; 0; 0; 3.1; 9.5 | — |
| SECONDARY Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
46.2; 57.1; 3.8; 11.5; 89.2; 92.1 | — |
| SECONDARY Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16 |
0; 4.6; 17.5; 0; 0; 1.6 | — |
| SECONDARY Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
95.4; 96.8; 57.7; 65.4; 90.8; 88.9 | — |
| SECONDARY Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16 |
0.4; 20.1; 23.6; 0.0; 45.3; 44.9 | — |
| SECONDARY Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52 |
89.4; 90.6; 58.7; 51.9; 91.6; 92.1 | — |
| SECONDARY Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16 |
0.0; -5.7; -6.3; -0.2; -12.1; -12.5 | — |
| SECONDARY Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52 |
-22.8; -24.3; -18.3; -11.3; -23.4; -24.7 | — |
| SECONDARY Change From Baseline in Body Surface Area (BSA) Involvement by Psoriatic Lesions at Week 48 |
-31.7; -34.4; -37.1; -27.7 | — |
| SECONDARY Change From Baseline in Nail Psoriasis Area and Severity Index (NAPSI) Score at Week 16 |
-0.2; -1.2; -1.5 | — |
| SECONDARY Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52 |
-2.2; -2.4; -1.7; -0.7; -2.3; -2.7 | — |
| SECONDARY Percent Change From Baseline in NAPSI Score at Week 16 |
1.0; 31.6; 39.1 | — |
| SECONDARY Percent Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52 |
57.9; 61.1; 48.7; 23.6; 59.6; 67.4 | — |
| SECONDARY Percentage of Participants With a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Week 16 |
10.5; 74.1; 82.8 | — |
| SECONDARY Percentage of Participants With an Ss-IGA Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Weeks 28, 48 and 52 |
86.2; 86.2; 90.5; 70.8; 84.5; 84.5 | — |
| SECONDARY Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 16 |
3.5; 48.3; 63.8; 8.8; 41.4; 22.4 | — |
| SECONDARY Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52 |
63.8; 70.7; 66.7; 50.0; 31.0; 22.4 | — |
| SECONDARY Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 8 and 16 |
6.6; 43.8; 43.3; 6.6; 64.1; 68.3 | — |
| SECONDARY Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 28, 36, 48, and 52 |
70.3; 75.0; 50.0; 68.0; 79.7; 83.3 | — |
| SECONDARY Change From Baseline in the DLQI Total Score at Week 8 |
-0.4; -7.5; -7.0 | — |
| SECONDARY Change From Baseline in the DLQI Total Score at Weeks 28, 36, 48, 52 |
-9.0; -8.9; -9.5; -5.5; -9.2; -9.2 | — |
| SECONDARY Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 8 and 16 |
17.2; 61.5; 58.7; 20.3; 67.7; 69.8 | — |
| SECONDARY Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 28, 36, 48, and 52 |
69.2; 73.0; 65.4; 57.7; 72.3; 68.3 | — |
| SECONDARY Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Week 16 |
0.05; 0.20; 0.18 | — |
| SECONDARY Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Weeks 28 and 48 |
0.20; 0.20; 0.25; 0.14; 0.20; 0.21 | — |
| SECONDARY Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 16 |
2.45; 21.20; 18.43 | — |
| SECONDARY Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Weeks 28, 48 |
22.94; 20.87; 20.73; 11.62; 20.88; 21.70 | — |
| SECONDARY Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Week 16 |
0.3; 7.4; 7.3; 1.3; 4.0; 5.3 | — |
| SECONDARY Change From Baseline in the PCS and MCS Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 28 and 48 |
7.7; 8.9; 6.4; 5.4; 8.2; 8.4 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Week 16 |
0.9; -2.4; -1.9; -7.7; -30.9; -33.8 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48 |
-3.0; -2.8; -4.0; -0.1; -35.1; -33.5 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16 |
0; 27.3; 10.0; 0; 18.2; 0 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52 |
36.4; 40.0; 66.7; 0; 27.3; 40.0 | — |
| SECONDARY Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16 |
-7.4; 41.1; -8.8; 14.1; 20.5; 22.2 | — |
| SECONDARY Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52 |
54.9; 60.6; 33.3; -100.0; 66.0; 94.4 | — |
| SECONDARY Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16 |
0.2; -3.8; -1.6; -0.4; -1.2; -0.4 | — |
| SECONDARY Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52 |
-4.0; -4.1; -1.0; 1.8; -2.5; -3.4 | — |
| SECONDARY Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 4, 8, 16 |
13.70; 3.99; 10.32; 2.36; 38.19; 45.15 | — |
| SECONDARY Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 28, 36, 48, 52 |
-37.67; 73.28; 51.18; 40.96; -26.65; 68.21 | — |
| SECONDARY Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 4, 8, 16 |
12.55; 39.64; 58.81; 2.50; 44.50; 63.10 | — |
| SECONDARY Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 28, 36, 48, and 52 |
-46.83; 71.26; 45.85; 61.23; -48.87; 75.55 | — |
| SECONDARY Percentage of Participants Who Achieved Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Weeks 4, 8 and 16 |
10.0; 36.4; 10.0; 20.0; 45.5; 20.0 | — |
| SECONDARY Percentage of Participants Who Achieved HAQ-DI Response at Weeks 28, 36, 48, 52 |
45.5; 30.0; 66.7; 25.0; 54.5; 30.0 | — |
Summary
The purpose of this study is to demonstrate the superiority of CNTO 1959 (guselkumab) to placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches).
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months before Screening
- Have a PASI greater than or equal to (>=) 12 at Screening and at Baseline
- Have an IGA >= 3 at Screening and at Baseline
- Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
- Be a candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment)
Exclusion Criteria
- Has a history of or current signs or symptoms of severe, progressive, or uncontrolled cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances
- Has unstable cardiovascular disease, defined as a recent clinical deterioration (example, unstable angina, atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months before Screening
- Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before Screening
- 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 and/or splenomegaly
- Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
Data sourced from ClinicalTrials.gov (NCT02325219). 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.