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

Primary Purpose

Plaque Psoriasis Vulgaris

Status

Terminated

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

AZD0284 oral solution 2.5 mg/mL

Placebo

About this trial

This is an interventional treatment trial for Plaque Psoriasis Vulgaris focused on measuring Plaque psoriasis, PASI, BSA, sPGA, P-VAS, IL17A-, CCL20, PK

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

AZD0284

Arm Description

Placebo for AZD0284 oral solution

AZD0284 oral solution 2.5 mg/mL

Outcomes

Primary Outcome Measures

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

Change (percent improvement) in Psoriasis Area and Severity Index score(PASI) compared to placebo

Secondary Outcome Measures

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

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

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

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

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

Cmax : maximum observed plasma concentration

Maximum observed plasma concentration (Cmax) will be assessed

tmax time to reach Cmax

The time to reach the maximum observed plasma concentration (Cmax) will be assessed

Cmin minimum observed plasma concentration

The minimum observed plasma concentration (Cmin) will be assessed

AE(s) and SAE(s)

Safety evaluation will include the assessment of adverse and serious adverse events over the course of the study

Full Information

NCT ID

NCT03310320

First Posted

October 11, 2017

Last Updated

April 24, 2019

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT03310320

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Why Stopped

The study is temporarily suspended due to preclinical findings that are currently under evaluation

Study Start Date

November 29, 2017 (Actual)

Primary Completion Date

April 18, 2018 (Actual)

Study Completion Date

April 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis Vulgaris

Keywords

Plaque psoriasis, PASI, BSA, sPGA, P-VAS, IL17A-, CCL20, PK

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

This is a randomised, double-blind, placebo-controlled, multi-centre, parallel group Phase 1b study in patients with moderate to severe plaque psoriasis. The study is 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 and Severity Index score and biomarkers associated with the mechanism of disease and AZD0284. It comprises 8 clinic visits over approximately 10 weeks including screening visit.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The study is double-blind; patients, study site personnel and AZ personnel involved in the evaluation of the data must be kept blinded. Packaging and labelling of study drug will be performed in a way that ensures blinding.

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo for AZD0284 oral solution

Arm Title

AZD0284

Arm Type

Experimental

Arm Description

AZD0284 oral solution 2.5 mg/mL

Intervention Type

Drug

Intervention Name(s)

AZD0284 oral solution 2.5 mg/mL

Other Intervention Name(s)

AZD0284

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo for AZD0284 oral solution, twice daily for 4 weeks

Primary Outcome Measure Information:

Title

Reduction from baseline to the end of treatment, in gene expression level of IL-17A and CCL20 relative to placebo.

Description

Reduction from baseline to the end of treatment, in gene expression level of IL-17A and CCL20 relative to placebo.

Time Frame

4 weeks

Title

Percent improvement from baseline to the end of treatment in individual Psoriasis Area and Severity Index (PASI) compared to placebo

Description

Change (percent improvement) in Psoriasis Area and Severity Index score(PASI) compared to placebo

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Proportion of patients achieving 75 % reduction from baseline in PASI score, i.e. PASI 75, at week 4

Description

Percent patients acheiving a 75% reduction in PASI score

Time Frame

4 weeks

Title

Proportion of patients achieving 50 % reduction from baseline in PASI score, i.e. PASI 50, at week 4

Description

Percent patients acheiving a 50% reduction in PASI score

Time Frame

4 weeks

Title

Reduction in static physician's global assessment (sPGA) score from baseline at week4

Description

The change in the Static physician's global assessment (sPGA) score will be assessed

Time Frame

4 weeks

Title

Percent improvement from baseline in involved body surface area (BSA) at week 4

Description

The percent change in the involved body surface area (BSA) will be assessed

Time Frame

4 weeks

Title

Reduction in the pruritus visual analogue scale (pVAS) score from baseline, at week 4

Description

The reduction in the pruritus visual analogue scale (pVAS) score as determined by the patient will be assessed

Time Frame

4 weeks

Title

Cmax : maximum observed plasma concentration

Description

Maximum observed plasma concentration (Cmax) will be assessed

Time Frame

4 weeks

Title

tmax time to reach Cmax

Description

The time to reach the maximum observed plasma concentration (Cmax) will be assessed

Time Frame

4 weeks

Title

Cmin minimum observed plasma concentration

Description

The minimum observed plasma concentration (Cmin) will be assessed

Time Frame

4 weeks

Title

AE(s) and SAE(s)

Description

Safety evaluation will include the assessment of adverse and serious adverse events over the course of the study

Time Frame

Approximately 8 weeks throughout the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ioannis Psallidas, Phd

Organizational Affiliation

AstraZeneca R&D, Gothenburg, Sweden

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Research Site

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Facility Name

Research Site

City

Koebenhavn

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Research Site

City

Odense

ZIP/Postal Code

5000

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

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

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