Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03168256 | CF101 Therapy in Patients With Moderate-to-severe Plaque Psoriasis | PHASE3 | COMPLETED | 528 | — | — | Sep 15, 2018 | Apr 27, 2022 | Jun 28, 2022 | 30 | Bosnia and Herzegovina, Bulgaria +7 |
| NCT01265667 | Trial of CF101 to Treat Patients With Psoriasis | PHASE2 | COMPLETED | 293 | — | — | Jul 1, 2011 | May 1, 2015 | Nov 18, 2020 | 18 | United States, Bulgaria +2 |
| NCT00428974 | Safety and Efficacy Study of CF101 to Treat Psoriasis | PHASE2 | COMPLETED | 76 | — | — | Jun 1, 2007 | Sep 1, 2009 | Feb 8, 2023 | 4 | Israel |
Evaluate the efficacy of oral CF101 2 mg or 3 mg twice daily (BID) in patients with moderate-to-severe plaque psoriasis, compared with placebo, as determined by the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) at Week 16 (superiority)
Nature, incidence and severity of treatment-emergent adverse events
Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)
PASI scale is sum of redness, thickness, and scale scores, ranging from 0 (no disease) to 72 (most severe possible score); lower scores, i..e., negative change from baseline, indicate improvement
| Arm | Type | Description |
|---|---|---|
| CF101 2mg | EXPERIMENTAL | CF101 2mg, orally q12 hours |
| CF101 3mg | EXPERIMENTAL | CF101 3mg, orally q12 hours |
| Apremilast 30mg | ACTIVE_COMPARATOR | Apremilast 30mg, orally q12 hours |
| Placebo | PLACEBO_COMPARATOR | Placebo control , orally q12 hours |
| CF101 2 mg | EXPERIMENTAL | CF101 2mg oral tablets |
| CF101 1 mg | EXPERIMENTAL | - |
| CF101 4mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CF101 2mg | DRUG | CF101 tablets, 2mg BID for 16 weeks |
| CF101 3mg | DRUG | CF101 tablets, 3mg BID for 16 weeks |
| Apremilast 30mg | DRUG | Apremilast tablets, 30mg BID for 16 weeks |
| Placebo Oral Tablet | DRUG | Placebo tablets, BID for 16 weeks |
| CF101 | DRUG | orally q12h |
| Placebo | DRUG | orally q12h |
| CF101 1mg | DRUG | CF101 1 mg q12 hours for 12 weeks |
| CF101 4mg | DRUG | CF101 4 mg q12 hours for 12 weeks |
Inclusion Criteria: 1. Male or female, 18 to 80 years of age, inclusive; 2. Diagnosis of moderate-to-severe chronic plaque-type psoriasis with BSA involvement ≥10%, as judged by the Investigator; 3. PASI score ≥12 (Appendix 3) 4. Static PGA ≥3 (Appendix 2) 5. Candidate for systemic treatment or pho...