Ignite Creation Date:
2024-05-06 @ 10:39 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03310320
Status:
TERMINATED
Last Update Posted:
2019-04-25
First Post:
2017-10-11
Brief Title:
Study to Determine if AZD0284 is Effective and Safe in Treating Plaque Psoriasis
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study is temporarily suspended due to preclinical findings that are currently under evaluation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DERMIS
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-002351-29 | EUDRACT_NUMBER | None | None |