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

NCT ID: NCT03310320

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-29
• Study Completion Date: 2018-04-18

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

Conditions

Plaque Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo for AZD0284 oral solution

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for AZD0284 oral solution, twice daily for 4 weeks

AZD0284

AZD0284 oral solution 2.5 mg/mL

Group Type: EXPERIMENTAL

AZD0284 oral solution 2.5 mg/mL

Intervention Type: DRUG

AZD0284 oral solution 2.5 mg/mL, 100 mg twice daily for for 4 weeks

Interventions

AZD0284 oral solution 2.5 mg/mL

AZD0284 oral solution 2.5 mg/mL, 100 mg twice daily for for 4 weeks

Intervention Type: DRUG

Placebo

Placebo for AZD0284 oral solution, twice daily for 4 weeks

Intervention Type: DRUG

Other Intervention Names

AZD0284

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ioannis Psallidas, Phd

Role: STUDY_DIRECTOR

AstraZeneca R&D, Gothenburg, Sweden

Locations

Research Site

Aarhus C, , Denmark

Research Site

Copenhagen, , Denmark

Research Site

Hellerup, , Denmark

Research Site

Odense, , Denmark

Countries

Denmark

Other Identifiers

2017-002351-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D7800C00003

Identifier Type: -

Identifier Source: org_study_id