Phase 2
Completed N=293
A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis
Source: ClinicalTrials.gov NCT01483599 ↗Enrolled (actual)
293
Serious AEs
1.8%
Results posted
Aug 2017
Primary outcomePrimary: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 — 7.1; 34.1; 61.0; 78.6 percentage of participants — p=0.002
Summary
The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the treatment of patients with moderate to severe plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 |
7.1; 34.1; 61.0; 78.6; 85.7; 83.3 | 0.002 sig |
| SECONDARY Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 |
4.8; 43.9; 75.6; 81.0; 78.6; 81.0 | < 0.001 sig |
| SECONDARY Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16 |
34.1; 61.0; 78.6; 85.7; 83.3; 58.1 | — |
| SECONDARY Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40 |
35.3; 59.5; 71.1; 76.9; 81.1; 48.6 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 |
-2.3; -6.2; -10.3; -11.1; -10.8; -11.4 | 0.008 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
- Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)
- Must be considered, in the opinion of the investigator, suitable candidates for adalimumab therapy
- If a woman, she must be postmenopausal, or if premenopausal, she must be either surgically sterile, practicing a highly effective method of birth control, or not heterosexually active during the study and for 5 months after receiving the last dose of study drug
- If a man, he must agree to use a double-barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 5 months after receiving the last dose of study drug.
Exclusion Criteria
- History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- Has a contra-indication to anti-TNF therapy
- Has a history of chronic or recurrent infectious disease
- Has a nonplaque form of psoriasis or has drug-induced psoriasis
- Has been previously treated with adalimumab
- Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23, (including but not limited to ustekinumab, briakinumab [ABT-874], AIN457, and SCH900222) within 6 months of the first administration of study agent.
Data sourced from ClinicalTrials.gov (NCT01483599). 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.