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

NCT03310320 | Terminated Phase 1

• 2 other identifiers: D7800C000032017-002351-29
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

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.

Conditions

Plaque Psoriasis Vulgaris

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 (9)

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

  4 weeks

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

  4 weeks

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

  4 weeks

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

  4 weeks

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

  4 weeks

Study Arms (2)

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

AZD0284 oral solution 2.5 mg/mL DRUG

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

Also known as: AZD0284

AZD0284

Placebo DRUG

Placebo for AZD0284 oral solution, twice daily for 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Aarhus C, 8000, Denmark

Location

Research Site

Copenhagen, 2400, Denmark

Location

Research Site

Hellerup, 2900, Denmark

Location

Research Site

Odense, 5000, Denmark

Location

MeSH Terms

Interventions

AZD-0284

Study Officials

• Ioannis Psallidas, Phd

  AstraZeneca R&D, Gothenburg, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 16, 2017
• Study Start: November 29, 2017
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)