Plaque Psoriasis VulgarisPhase 1DERMISNCT03310320
Study to Determine if AZD0284 is Effective and Safe in Treating Plaque Psoriasis
A Phase 1 study testing AZD0284 oral solution 2.5 mg/mL in people with Plaque Psoriasis Vulgaris, run by AstraZeneca at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plaque Psoriasis Vulgaris
- What is being tested?
- AZD0284 oral solution 2.5 mg/mL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 4 sitesDenmark
- Study dates
- 29 Nov 2017to 18 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Research Site
Aarhus C, 8000
Research Site
Copenhagen, 2400
Research Site
Hellerup, 2900
Research Site
Odense, 5000
About this study
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
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.
Read the 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
- Conditions
- Plaque Psoriasis Vulgaris
- Being tested
- AZD0284 oral solution 2.5 mg/mL, Placebo
- Keywords
- Plaque psoriasis, PASI, BSA, sPGA, P-VAS, IL17A-, CCL20, PK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0284 oral solution 2.5 mg/mLDrug
Also called AZD0284
AZD0284 oral solution 2.5 mg/mL, 100 mg twice daily for for 4 weeks
PlaceboDrug
Placebo for AZD0284 oral solution, twice daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo for AZD0284 oral solution Receives: Drug: Placebo |
| AZD0284 | Experimental | AZD0284 oral solution 2.5 mg/mL Receives: Drug: AZD0284 oral solution 2.5 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4 weeks
Secondary outcomes (9)
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
Measured: 4 weeks
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
Measured: 4 weeks
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
Measured: 4 weeks
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
Measured: 4 weeks
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
Measured: 4 weeks
Cmax : maximum observed plasma concentration
Maximum observed plasma concentration (Cmax) will be assessed
Measured: 4 weeks
tmax time to reach Cmax
The time to reach the maximum observed plasma concentration (Cmax) will be assessed
Measured: 4 weeks
Cmin minimum observed plasma concentration
The minimum observed plasma concentration (Cmin) will be assessed
Measured: 4 weeks
AE(s) and SAE(s)
Safety evaluation will include the assessment of adverse and serious adverse events over the course of the study
Measured: Approximately 8 weeks throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start29 Nov 2017
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Why it stopped: The study is temporarily suspended due to preclinical findings that are currently under evaluation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ioannis Psallidas, Phd, Study director, AstraZeneca R&D, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310320
- Sponsor's protocol ID
- D7800C00003
- Other IDs
- 2017-002351-29, 2017
- Acronym
- DERMIS
- Status last verified
- Apr 2019
- First submitted
- 11 Oct 2017
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03310320
- Acronym / sponsor ID
- DERMIS / D7800C00003
- Conditions
- Plaque Psoriasis Vulgaris
- Keywords
- Plaque psoriasis, PASI, BSA, sPGA, P-VAS, IL17A-, CCL20, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is temporarily suspended due to preclinical findings that are currently under evaluation
- Enrolment
- 9 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for AZD0284 oral solution |
| AZD0284 | Experimental | Drug: AZD0284 oral solution 2.5 mg/mLAZD0284 oral solution 2.5 mg/mL |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0284 oral solution 2.5 mg/mLAlso: AZD0284AZD0284 oral solution 2.5 mg/mL, 100 mg twice daily for for 4 weeks | Drug | AZD0284 |
| PlaceboPlacebo for AZD0284 oral solution, twice daily for 4 weeks | Drug | Placebo |
Primary outcome
Reduction from baseline to the end of treatment, in gene expression level of IL-17A and CCL20 relative to placebo.
Time frame: 4 weeks
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
Time frame: 4 weeks
Change (percent improvement) in Psoriasis Area and Severity Index score(PASI) compared to placebo
9 secondary outcomes
Proportion of patients achieving 75 % reduction from baseline in PASI score, i.e. PASI 75, at week 4
Time frame: 4 weeks
Proportion of patients achieving 50 % reduction from baseline in PASI score, i.e. PASI 50, at week 4
Time frame: 4 weeks
Reduction in static physician's global assessment (sPGA) score from baseline at week4
Time frame: 4 weeks
Percent improvement from baseline in involved body surface area (BSA) at week 4
Time frame: 4 weeks
Reduction in the pruritus visual analogue scale (pVAS) score from baseline, at week 4
Time frame: 4 weeks
Cmax : maximum observed plasma concentration
Time frame: 4 weeks
tmax time to reach Cmax
Time frame: 4 weeks
Cmin minimum observed plasma concentration
Time frame: 4 weeks
AE(s) and SAE(s)
Time frame: Approximately 8 weeks throughout the study
Results and safety
The study was stopped early (reason given: The study is temporarily suspended due to preclinical findings that are currently under evaluation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Plaque Psoriasis Vulgaris
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Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis Psallidas, Phd study director
AstraZeneca R&D, Gothenburg, Sweden
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD0284 oral solution 2.5 mg/mL in people with Plaque Psoriasis Vulgaris, run by AstraZeneca at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study is temporarily suspended due to preclinical findings that are currently under evaluation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction from baseline to the end of treatment, in gene expression level of IL-17A and CCL20 relative to placebo. (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.