Phase 3
Completed N=293
Trial of CF101 to Treat Patients With Psoriasis
Source: ClinicalTrials.gov NCT01265667 ↗Enrolled (actual)
293
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks — 12; 10 Participants
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
Eligible patients with Psoriasis will be treated with CF101 or placebo twice daily for 16 weeks. All subjects will receive open-lable CF101 in weeks 17-32.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks |
12; 10 | — |
| SECONDARY Number of Subjects Achieving PGA of 0 or 1 |
9; 5 | — |
| SECONDARY Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75 |
31; 17 | — |
| SECONDARY Nature and Frequency of Adverse Events |
37; 29; 8; 3; 10; 13 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 to 80 years of age, inclusive
- Diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area involvement ≥10%
- Duration of psoriasis of at least 6 months
- Physician global assessment (PGA) ≥3
- Candidate for systemic treatment or phototherapy for psoriasis
- Electrocardiogram (ECG) is normal
- Females of child-bearing potential must have a negative serum pregnancy test
- Females of child-bearing potential must be willing to use 2 methods of contraception
- Ability to complete the study in compliance with the protocol
- Ability to understand and provide written informed consent.
Exclusion Criteria
- Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis
- Treatment with systemic retinoids, corticosteroids, or immunosuppressive agents within 4 weeks of the Baseline visit
- Treatment with high potency topical corticosteroids, keratolytics, or coal tar within 2 weeks of the Baseline visit
- Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit
- Treatment with a biological agent within a period of time equal to 5 times its circulating half-life
- Treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the Baseline visit
- Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal
- Liver aminotransferase levels greater than the laboratory's upper limit of normal
- Significant acute or chronic medical or psychiatric illness
- Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to Screening visit.
Data sourced from ClinicalTrials.gov (NCT01265667). 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.