Psoriasis
Conditions
Keywords
Plaque Type Psoriasis, Topical
Brief summary
The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle, applied twice daily for 12 weeks, in the treatment of plaque type psoriasis
Detailed description
This is a single center, randomized, double-blind, vehicle-controlled, bilateral design. Patients will apply both test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily for 12 weeks. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test article will be applied to one plaque and the other test article to an anatomically distinct plaque. All efficacy evaluations will be measured from only the two plaques identified at the baseline visit.
Interventions
DRUGAN2728
AN2728 Ointment, 5%, twice daily for 12 weeks
DRUGOintment vehicle
Ointment vehicle, twice daily for 12 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female \>18 years of age at time of enrollment 2. The clinical diagnosis of stable plaque psoriasis 3. Two target plaques of similar severity * ≥ 5 cm2 but ≤ 100 cm2 computed by multiplying the greatest diameter of the plaque by the diameter of the plaque perpendicular to the greatest diameter * Bilaterally located (right/left) plaques on the arms or distinct plaques located on the trunk. Plaques located on the trunk must be separated by at least 10 cm and will be designated by the Investigator as either left/right or front/back or upper/lower * Overall target plaque severity score (OTPSS) of 2-4 (mild to moderate) with no more than a 1 point difference in the scores of the individual plaques 4. Normal or not clinically significant screening laboratory results 5. Willing and able to apply study drug as directed, comply with study instructions and commit to all follow-up visits 6. Ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol related procedures
Exclusion criteria
1. Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation 2. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below). 3. Known sensitivity to any of the components of the study medication 4. Spontaneously improving or rapidly deteriorating psoriatic plaques or pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis 5. Concomitant use of topical or systemic therapies that might alter the course of psoriasis 6. Females of child bearing potential. Females must be post-menopausal or surgically sterile (oophorectomy). 7. Washout periods of: * Topical drugs that might alter the course of psoriasis: 2 weeks * Oral retinoids: 8 weeks * Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks * PUVA: 4 weeks * UVB therapy: 4 weeks * Use of emollients/moisturizers on area(s) to be treated: 2 days to baseline visit 8. AIDS or AIDS related illness 9. Concurrent participation in another drug research study or within 30 days of enrollment 10. Use of lithium or hydroxychloroquine containing products (i.e. Plaquenil) 11. Use of a beta-blocking medication (i.e. propranolol) if the dose has not been stabilized for at least 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84 | Day 84 | OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 84 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 7, 14, 28, 42, 56, 70, 91 | OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 28, 42, 56, 70 and 91 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque vs. vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AN2728 5% Ointment + Ointment Vehicle AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficiency | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | AN2728 5% Ointment + Ointment Vehicle |
|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 8.63 |
| Gender Female | 0 Participants |
| Gender Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 29 |
| serious Total, serious adverse events | 1 / 29 |
Outcome results
Primary
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 84 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
Time frame: Day 84
Population: ITT population included all randomized participants who received the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84 | Ointment treated plaque vs. vehicle treated plaque | 53.3 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84 | Vehicle treated plaque vs. ointment treated plaque | 30.0 percentage of participants |
p-value: 0.232-sided sign test
Secondary
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 28, 42, 56, 70 and 91 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque vs. vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
Time frame: Day 7, 14, 28, 42, 56, 70, 91
Population: ITT population included all randomized participants who received the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 7: Ointment treated vs.vehicle treated plaque | 10.0 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 7: Vehicle treated vs.ointment treated plaque | 10.0 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 14: Ointment treated vs.vehicle treated plaque | 43.3 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 14: Vehicle treated vs.ointment treated plaque | 10.0 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 28: Ointment treated vs.vehicle treated plaque | 60.0 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 28: Vehicle treated vs.ointment treated plaque | 3.3 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 42: Ointment treated vs.vehicle treated plaque | 60.0 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 42: Vehicle treated vs.ointment treated plaque | 6.7 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 56: Ointment treated vs.vehicle treated plaque | 60.0 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 56: Vehicle treated vs.ointment treated plaque | 16.7 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 70: Ointment treated vs.vehicle treated plaque | 56.7 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 70: Vehicle treated vs.ointment treated plaque | 23.3 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 91: Ointment treated vs.vehicle treated plaque | 40.0 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 | Day 91: Vehicle treated vs.ointment treated plaque | 30.0 percentage of participants |