E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate-to-Severe Plaque Psoriasis |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objectives of this study are to:
-Evaluate the efficacy of oral CF101 when administered at 2 mg twice daily (BID) for 16 weeks, compared with placebo, in patients with moderate-to-severe plaque psoriasis; and
-Evaluate the safety of oral CF101 in this patient population
|
|
E.2.2 | Secondary objectives of the trial |
-Evaluate the efficacy and safety of continued dosing of CF101 over 32 weeks and
-Evaluate the pharmacokinetics (PK) of CF101 in this population |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacokinetics (PK) assesment included in Protocol Amendment #7 dated 18 Aug 2014 - Plasma PK will be evaluated from blood samples taken within one hour prior to the morning dose of CF101 and at 1, 2, 3, 4, 6 and 8 hours post-dose at 1 of the following visits: Week 16, 20, 24, 28, or 32.
PK data in the treated population will enable PK analysis and much more detailed analyses of the relationship between body weight/body mass index, exposure and efficacy of CF101. |
|
E.3 | Principal 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. Duration of psoriasis of at least 6 months;
4. PGA ≥3 (Appendix 2);
5. Candidate for systemic treatment or phototherapy for psoriasis;
6. Electrocardiogram (ECG) is normal or shows abnormalities which, in the judgment of the Investigator, are not clinically significant;
7. Females of child-bearing potential must have a negative serum pregnancy test at screening;
8. Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the Investigator (for example, oral contraceptive pills plus a barrier method) to be eligible for, and continue participation in, the study;
9. Ability to complete the study in compliance with the protocol; and
10. Ability to understand and provide written informed consent.
|
|
E.4 | Principal exclusion criteria |
1. Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis;
2. Treatment with systemic retinoids, corticosteroids, or immunosuppressive agents (e.g., methotrexate, cyclosporine) within 4 weeks of the Baseline visit;
3. Treatment with high potency topical dermatological corticosteroids (Class I-III), Vitamin D analogs, keratolytics, or coal tar (other than on the scalp, palms, groin, and/or soles) within 2 weeks of the Baseline visit;
4. Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated need for either of these therapies during the study period;
5. Treatment with a biological agent (etanercept, adalimumab, efalizumab, infliximab, ustekinumab, alefacept or others, including investigational agents) within a period of time equal to 5 times its circulating half-life, or 30 days, whichever is longer, prior to the Baseline visit;
6. Treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the Baseline visit, or anticipated need for such drugs during the study period, unless dose has been stable for 3 months prior to the Screening visit and will remain stable throughout the trial;
7. Serum creatinine level greater than 1.5 times the laboratory’s upper limit of normal;
8. Liver aminotransferase levels greater than the laboratory’s upper limit of normal;
9. Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator;
10. Active drug or alcohol dependence;
11. Previous receipt of CF101;
12. Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the study;
13. Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to Screening visit. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Evaluate the efficacy of oral CF101 when administered at 2 mg twice daily (BID) for 16 weeks, compared with placebo, in patients with moderate-to-severe plaque psoriasis; and
• Evaluate the safety of oral CF101 in this patient population
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
-Evaluate the efficacy of continued dosing of CF101 over 32 weeks.
-Evaluate the pharmacokinetics (PK) of CF101 in this population |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Blinded for the first 16-week dosing period, and open-label for the subsequent 16-week dosing period |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last patient, last visit. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |