Study to Determine if AZD0284 is Effective and Safe in Treating Plaque Psoriasis

Phase 1

Terminated

• Conditions: Plaque Psoriasis Vulgaris
• Interventions: Drug: Placebo; Drug: AZD0284 oral solution 2.5 mg/mL

• Registration Number: NCT03310320
• Lead Sponsor: AstraZeneca

Brief Summary

The Sponsor is developing the study drug, AZD0284, for the potential treatment of Plaque psoriasis. Psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. The severity of the disease varies, but in many cases it can have a major impact on their quality of life if not adequately treated.

The purpose of the study is to determine the short term safety, pharmacodynamic and clinical effect of AZD0284 in patients with psoriasis.

Detailed Description

This is a randomised, double-blind, placebo-controlled, multi-centre, parallel group Phase 1b study, designed to evaluate the pharmacodynamic effects, clinical efficacy and safety of AZD0284 compared with placebo as measured by the relative change from baseline in Psoriasis Area Severity Index (PASI score), other disease assessments of involved body surface area (BSA), static physicians global assessment score (sPGA), pruritis and biomarkers associated with the mechanism of disease and AZD0284. Disease activity will be assessed throughout the study as will changes in skin biopsy biomarkers. The study population will be comprised of patients with moderate to severe plaque psoriasis as defined by PASI score, BSA and sPGA.

Following completion of screening assessments and meeting all eligibility criteria, patients will be randomised to receive AZD0284 or placebo for 4 weeks of treatment followed by a 4 week follow up period

Study Timeline

• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-16
• Study Start: 2017-11-29
• Primary Completion: 2018-04-18
• Study Completion: 2018-04-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Provision of signed informed consent prior to any study specific procedures.
• At least 6 months documented history with a diagnosis of moderate to severe plaque psoriasis as defined by the Psoriasis Area and Severity Index (PASI), psoriasis Body Surface Area (BSA) and static Physician Global Assessment (sPGA).

Exclusion Criteria

• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
• History and/or presence of tuberculosis, hepatitis, HIV. Other opportunistic infections within 6 months of the study.
• Clinically significant laboratory abnormalities.
• Clinically important abnormalities in rhythm, conduction or morphology of the digital Electrocardiogram (ECG) as considered by the Investigator may interfere with the interpretation of study data.
• Current treatment or treatment for psoriasis with biological therapies within 6 months of study.
• Efficacy and safety failure of biologic therapies targeting the IL-17 and IL12/23 pathway at any time.
• Current treatment or history of treatment for psoriasis with non-biological systemic medications within 4 weeks of Day 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo for AZD0284 oral solution
AZD0284	AZD0284 oral solution 2.5 mg/mL	AZD0284 oral solution 2.5 mg/mL

Primary Outcome Measures

Name	Time	Method
Reduction from baseline to the end of treatment, in gene expression level of IL-17A and CCL20 relative to placebo.	4 weeks	Reduction from baseline to the end of treatment, in gene expression level of IL-17A and CCL20 relative to placebo.
Percent improvement from baseline to the end of treatment in individual Psoriasis Area and Severity Index (PASI) compared to placebo	4 weeks	Change (percent improvement) in Psoriasis Area and Severity Index score(PASI) compared to placebo

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving 75 % reduction from baseline in PASI score, i.e. PASI 75, at week 4	4 weeks	Percent patients acheiving a 75% reduction in PASI score
Reduction in static physician's global assessment (sPGA) score from baseline at week4	4 weeks	The change in the Static physician's global assessment (sPGA) score will be assessed
Proportion of patients achieving 50 % reduction from baseline in PASI score, i.e. PASI 50, at week 4	4 weeks	Percent patients acheiving a 50% reduction in PASI score
Cmax : maximum observed plasma concentration	4 weeks	Maximum observed plasma concentration (Cmax) will be assessed
tmax time to reach Cmax	4 weeks	The time to reach the maximum observed plasma concentration (Cmax) will be assessed
Cmin minimum observed plasma concentration	4 weeks	The minimum observed plasma concentration (Cmin) will be assessed
Percent improvement from baseline in involved body surface area (BSA) at week 4	4 weeks	The percent change in the involved body surface area (BSA) will be assessed
Reduction in the pruritus visual analogue scale (pVAS) score from baseline, at week 4	4 weeks	The reduction in the pruritus visual analogue scale (pVAS) score as determined by the patient will be assessed
AE(s) and SAE(s)	Approximately 8 weeks throughout the study	Safety evaluation will include the assessment of adverse and serious adverse events over the course of the study

Trial Locations

Locations (1)

Research Site; 🇩🇰 Odense, Denmark