Study to Determine if AZD0284 is Effective and Safe in Tr... | NCT03310320

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

NCT03310320

Sponsor

AstraZeneca

Status

Terminated

Last Update Posted

Apr 25, 2019Actual

Enrollment

9Actual

Phase

Phase 1

Conditions

Plaque Psoriasis Vulgaris

Interventions

AZD0284 oral solution 2.5 mg/mL
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017-002351-29	EudraCT Number

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Nov 29, 2017Actual

Primary Completion Date

Apr 18, 2018Actual

Completion Date

Apr 18, 2018Actual

First Submitted Date

Oct 11, 2017

First Submission Date that Met QC Criteria

Oct 11, 2017

First Posted Date

Oct 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2019

Last Update Posted Date

Apr 25, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo for AZD0284 oral solution	Drug: Placebo
AZD0284	Experimental	AZD0284 oral solution 2.5 mg/mL	Drug: AZD0284 oral solution 2.5 mg/mL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD0284 oral solution 2.5 mg/mL	Drug	AZD0284 oral solution 2.5 mg/mL, 100 mg twice daily for for 4 weeks	AZD0284

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ioannis Psallidas, Phd	AstraZeneca R&D, Gothenburg, Sweden	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aarhus C		8000	Denmark
Research Site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
C000720454	AZD-0284

Intervention 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 Info

Masking

Quadruple

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.

Who Masked

ParticipantCare ProviderInvestigatorOutcomes Assessor