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

Plaque Psoriasis Vulgaris Clinical Trial

— DERMIS  

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Study to Assess Efficacy and Safety of One Dose Level of Oral AZD0284 Given for Four Weeks, Compared to Placebo, in Patients With Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03310320
• Other study ID #: D7800C00003
• Secondary ID: 2017-002351-29
• Status: Terminated
• Phase: Phase 1
• Start date: November 29, 2017
• Est. completion date: April 18, 2018

Study information

• Verified date: April 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis Vulgaris
• Psoriasis

Intervention

Drug:
• AZD0284 oral solution 2.5 mg/mL
AZD0284 oral solution 2.5 mg/mL, 100 mg twice daily for for 4 weeks
• Placebo
Placebo for AZD0284 oral solution, twice daily for 4 weeks

Locations

Country	Name	City	State
Denmark	Research Site	Aarhus C
Denmark	Research Site	Hellerup
Denmark	Research Site	Koebenhavn
Denmark	Research Site	Odense

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction from baseline to the end of treatment, in gene expression level of IL-17A and CCL20 relative to placebo.	Reduction from baseline to the end of treatment, in gene expression level of IL-17A and CCL20 relative to placebo.	4 weeks
Primary	Percent improvement from baseline to the end of treatment in individual Psoriasis Area and Severity Index (PASI) compared to placebo	Change (percent improvement) in Psoriasis Area and Severity Index score(PASI) compared to placebo	4 weeks
Secondary	Proportion of patients achieving 75 % reduction from baseline in PASI score, i.e. PASI 75, at week 4	Percent patients acheiving a 75% reduction in PASI score	4 weeks
Secondary	Proportion of patients achieving 50 % reduction from baseline in PASI score, i.e. PASI 50, at week 4	Percent patients acheiving a 50% reduction in PASI score	4 weeks
Secondary	Reduction in static physician's global assessment (sPGA) score from baseline at week4	The change in the Static physician's global assessment (sPGA) score will be assessed	4 weeks
Secondary	Percent improvement from baseline in involved body surface area (BSA) at week 4	The percent change in the involved body surface area (BSA) will be assessed	4 weeks
Secondary	Reduction in the pruritus visual analogue scale (pVAS) score from baseline, at week 4	The reduction in the pruritus visual analogue scale (pVAS) score as determined by the patient will be assessed	4 weeks
Secondary	Cmax : maximum observed plasma concentration	Maximum observed plasma concentration (Cmax) will be assessed	4 weeks
Secondary	tmax time to reach Cmax	The time to reach the maximum observed plasma concentration (Cmax) will be assessed	4 weeks
Secondary	Cmin minimum observed plasma concentration	The minimum observed plasma concentration (Cmin) will be assessed	4 weeks
Secondary	AE(s) and SAE(s)	Safety evaluation will include the assessment of adverse and serious adverse events over the course of the study	Approximately 8 weeks throughout the study