PLAQUE PSORIASIS MedDRA version: 18.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: ZPL-3893787-18
Product Code: ZPL-3893787-18
Pharmaceutical Form: Capsule
INN or Proposed INN: ZPL-3893787-18
Current Spons
Sponsors
Ziarco Pharma Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study 1. A documented history of moderate to severe plaque psoriasis for at least 6 months prior to screening. 2. Male or female, aged =18 years. 3. Females should be either of non-child-bearing potential or must agree to use highly effective methods of contraception. Males with partners who are WOCBP must also use contraception. 4. Body weight of = 50 kg. 5. Body Mass Index of =34.9 kg/m2. 6. Psoriasis Area and Severity Index (PASI) =10 at both Screening and Day 0. 7. An Investigator’s Global Assessment (IGA) score = 3 at both Screening and Day 0. 8. Psoriasis affecting =10% BSA at Screening and Day 0. 9. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary completion and other study procedures. 10. Willing to avoid exposure to sun, UVA or UVB from screening until completion of the follow up visit. 11. Evidence of a personally signed and dated informed consent form, indicating that the subject has been informed of all pertinent aspects of the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1. Concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments. 2. Biologic treatments for psoriasis (e.g. Enbrel, Humira, Stelara, Cosentyx) within 3 months of the start of the Run-In. 3. Phototherapy (e.g. UVA, UVB, PUVA) within 4 weeks of the start of the Run-In. 4. Oral calcineurin inhibitors and immunosuppressants (e.g. cyclosporine, azathioprine, methotrexate) within 4 weeks of the start of the Run-In. 5. Systemic corticosteroids within 4 weeks of the start of the Run-In. 6. Oral antihistamines and leukotriene inhibitors and tricyclic antidepressants within 1 week of the start of the Run-In. 7. Topical steroids (any potency), topical calcineurin inhibitors (tacrolimus, pimecrolimus), salicylic acid and urea containing treatments and coaltar preparations, topical and oral retinoids and vitamin D derivatives, within 1 week of the start of the Run-In. 8. Subjects who are using any concomitant medication(s) that in the investigators’ opinion could affect psoriasis (e.g. ß-blockers, lithium) within the 3 months prior to the start of the Run-In. 9. Potent CYP1A inhibitors (e.g. ciprofloxacin, enoxacin, fluvoxamine) from the start of the Run-In. 10. Evidence of significant concomitant clinical disease that may need a change in management during the study or could interfere with the conduct or safety of this study (Stable well-controlled chronic conditions such as controlled hypertension (BP100 or 450 msec)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of an oral 30 mg dose of ZPL-3893787-18 when administered once daily, for 12 weeks, to subjects with moderate to severe plaque psoriasis.; Secondary Objective: To evaluate the safety and tolerability of 12 weeks treatment of once daily oral ZPL-3893787-18 (30 mg), in subjects with moderate to severe plaque psoriasis. To evaluate the ability of 12 weeks treatment of once daily oral ZPL-3893787-18 (30 mg) to reduce pruritus (itching) in subjects with moderate to severe plaque psoriasis. ;Primary end point(s): Percentage change from baseline in PASI score.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 12 ; Secondary end point(s): • PASI-75 response: Defined as a =75% reduction from baseline in PASI score • PASI 50 response: Defined as a =50% reduction from baseline in PASI score • Improvement in IGA (5-point IGA scale), defined as a reduction of at least 2 categories from baseline • Change from baseline in the daytime NRS for pruritus (worst itch) • Change from baseline in the night time NRS for pruritus (worst itch) • Change from baseline in the NRS for sleep disturbance • Change from baseline in duration of itching • Change from baseline in the verbal rating score (VRS) for pruritus | — |
Countries
Bulgaria, Poland, United Kingdom, United States
Contacts
Public ContactLynn Purkins
Ziarco Pharma Ltd
Outcome results
None listed