Status:
TERMINATED
Study to Determine if AZD0284 is Effective and Safe in Treating Plaque Psoriasis
Lead Sponsor:
AstraZeneca
Conditions:
Plaque Psoriasis Vulgaris
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 sc...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03310320
Start Date
November 29 2017
End Date
April 18 2018
Last Update
April 25 2019
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Aarhus C, Denmark, 8000
2
Research Site
Copenhagen, Denmark, 2400
3
Research Site
Hellerup, Denmark, 2900
4
Research Site
Odense, Denmark, 5000