Phase 2 N=129 Randomized Quadruple-blind Treatment

A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis

Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT02618616 ↗

Enrolled (actual)

129

Serious AEs

3.9%

Results posted

Jul 2021

Primary outcome: Primary: Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12 — -28.043; -37.361 percentage change — p=0.8495

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ZPL-3893787 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ziarco Pharma Ltd
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12	-28.043; -37.361	0.8495
SECONDARY PASI-50 and PASI-75 Responders at Week 12	21; 15; 12; 6	0.9058
SECONDARY Improvement in Investigator Global Assessment (IGA) at Week 12	10; 6; 7; 3	—
SECONDARY Change From Baseline in the Numerical Rating Scale (NRS) for Pruritus (Worst Itch) at Week 12	-1.40; -1.78	—
SECONDARY Patient Global Impression of Change (PGIC) a Week 12	12; 3; 14; 9; 22; 11	—
SECONDARY Change From Baseline in Body Surface Area (BSA) and Percentage Change From Baseline at Week 12	-2.8; -4.2	—
SECONDARY Change From Baseline in the Daytime and Night Time NRS for Pruritus (Worst Itch) at Week 12	4.32; 4.52; -1.40; -1.42; 4.19; 4.34	—
SECONDARY Change From Baseline in the NRS for Sleep Disturbance at Week 12	2.48; 2.74; -0.88; -0.93	—
SECONDARY Change From Baseline in Total, Daytime and Night Time Duration of Itching at Week 12	5.74; 6.68; -1.15; -1.16; 3.16; 3.57	—
SECONDARY Number of Participants for Each Verbal Rating Scale (VRS) Score for Pruritus at Week 12	2; 2; 21; 17; 52; 14	—

Summary

This was a randomized, double blind, placebo controlled, parallel group study in 129 subjects with moderate to severe psoriasis with a PASI score of at least 10. Following run-in, subjects were randomized and received either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks.

Eligibility Criteria

Inclusion Criteria

A documented history of moderate to severe plaque psoriasis for at least 6 months prior to screening.
Male or female, aged ≥18 years.
Psoriasis Area and Severity Index (PASI) ≥10 at both Screening and Day 0.
An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 0.
Psoriasis affecting ≥10% body surface area (BSA) at Screening and Day 0.

Exclusion Criteria

Current diagnosis of Pustular, Guttate, Erythrodermic, exfoliative or only nail psoriasis or a diagnosis of inverse psoriasis without having plaque psoriasis.
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.
Active skin infections (e.g. impetigo, abscesses) or any other clinically apparent infections.
Biologic treatments for psoriasis (e.g. Enbrel, Humira, Stelara, Cosentyx) within 3 months of the start of the Run-In.
Phototherapy (e.g. UVA, UVB, PUVA) within 4 weeks of the start of the Run-In.
Oral calcineurin inhibitors and immunosuppressants (e.g. cyclosporine, azathioprine, methotrexate) within 4 weeks of the start of the Run-In.
Systemic corticosteroids within 4 weeks of the start of the Run-In.
Oral antihistamines and leukotriene inhibitors and tricyclic antidepressants within 1 week of the start of the Run-In.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02618616). 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.