Phase 2 N=152 Randomized Quadruple-blind Treatment

Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis

Plaque Psoriasis · Psoriasis · Skin Diseases

Bottom Line

View on ClinicalTrials.gov: NCT03832738 ↗

Enrolled (actual)

152

Serious AEs

2.7%

Results posted

Aug 2021

Primary outcome: Primary: Percentage of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) at End-of-treatment (EOT) — 11.8; 22.0; 7.8 % of subjects achieving PASI-75 — p=0.558

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: JTE-451 Tablets (Drug); Placebo Tablets (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Akros Pharma Inc.
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) at End-of-treatment (EOT)	11.8; 22.0; 7.8	0.558
SECONDARY Percentage of Subjects Achieving a Minimum 50% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-50) at EOT	33.3; 42.0; 17.6	0.086
SECONDARY Percentage of Subjects Achieving a Minimum 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-90) at EOT	2.0; 6.0; 2.0	>0.999
SECONDARY Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at EOT	-30.33; -37.89; -17.53	—
SECONDARY Percentage of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1 at EOT	25.5; 28.0; 5.9	0.009 sig
SECONDARY Change From Baseline in Static Physician's Global Assessment (sPGA) Score at EOT	-0.96; -1.02; -0.54	—
SECONDARY Percent Change From Baseline in Psoriasis Body Surface Area (BSA) at EOT	-18.67; -19.03; -5.74	—
SECONDARY Change From Baseline in the Skindex-16 Overall Score at EOT	-10.029; -10.896; -3.386	—
SECONDARY Change From Baseline in the Skindex-16 Symptom Scale Scores at EOT	-8.905; -11.500; -2.170	—
SECONDARY Change From Baseline in the Skindex-16 Emotions Scale Scores at EOT	-10.411; -13.143; -5.953	—
SECONDARY Change From Baseline in the Skindex-16 Functioning Scale Scores at EOT	-10.392; -7.267; -0.764	—
SECONDARY Change From Baseline in Itch Numeric Rating Scale (NRS) at EOT	-1.302; -1.537; -0.547	—
SECONDARY Number of Subjects With Treatment-emergent Adverse Events	27; 28; 25; 24; 22; 25	—
SECONDARY JTE-451 Trough Plasma Concentrations at Week 16	575; 1210	—

Summary

Study to evaluate the efficacy and safety of JTE-451 administered for 16 weeks in subjects with moderate to severe plaque psoriasis.

Eligibility Criteria

Inclusion Criteria

Have had a history of moderate to severe plaque psoriasis for at least 6 months prior to Visit 1;
Subjects with moderate to severe plaque psoriasis covering ≥10% body surface area (BSA), with a psoriasis area and severity index (PASI) ≥12 and static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2

Exclusion Criteria

History of discontinuation of biologic therapies (including marketed and investigational drugs) directly targeting Interleukin (IL)-17A, IL-17A/F, IL-17 receptor A, IL-12/IL-23p40 or IL-23p19 due to lack of efficacy, according to the Investigator's judgment;
Prior exposure to retinoid-related orphan receptor (ROR)-γ inhibitors;
Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions (e.g., clinically-significant eczema or severe acne) at Visit 1;
History or presence of itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin within 12 months prior to Visit 1.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03832738). 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.