Psoriasis
Conditions
Keywords
Topical, Plaque type psoriasis
Brief summary
The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment B, 2.0% and 0.5%, compared to Ointment Vehicle B, applied once or twice daily for 12 weeks, in the treatment of plaque type psoriasis
Detailed description
This is a multicenter, randomized, double-blind, vehicle-controlled, bilateral design. Patients will apply both test article AN2728 Ointment B (0.5% or 2%), and Ointment B 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
Ointment B, 2% or 0.5% applied once or twice daily
DRUGPlacebo
Ointment B Vehicle applied once or twice daily
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female \>18 years of age at time of enrollment * Clinical diagnosis of stable plaque type psoriasis * Two target plaques of similar severity meeting the following criteria: * 5 cm2 and ≤ 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 plaques located on the trunk. Plaques located on the trunk must be separated by at least 10 cm 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 two target plaques * Willing and able to apply study drug as directed, comply with study instructions and commit to all follow-up visits * Ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol related procedures
Exclusion criteria
* Any dermatological conditions, disease state or physical condition that could interfere with clinical evaluations or might expose the patient to an unacceptable risk by study participation * Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below) * Clinically significant, abnormal Screening laboratory results (unless approved by the medical monitor) * Known sensitivity to any of the components of the study medication * Spontaneously improving or rapidly deteriorating psoriatic plaques or pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis * Concomitant use of topical or systemic therapies that might alter the course of psoriasis * Females of child bearing potential. Females must be post-menopausal (based on FSH levels) or surgically sterile (hysterectomy or bilateral oophorectomy) * Washout periods for exclusionary therapies: Oral retinoids: 8 weeks Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks Psoralens with UV-A (PUVA): 4 weeks Ultraviolet-B (UVB) therapy: 4 weeks Topical drugs that might alter the course of psoriasis: 2 weeks Use of emollients/moisturizers on area(s) to be treated: 2 days prior to Baseline visit * AIDS or AIDS-related illness * Concurrent participation in another drug or device research study or within 30 days prior to enrollment * Use of lithium- or hydroxychloroquine-containing products (e.g., Plaquenil) * Use of a beta-blocking medication (e.g., Propranolol) if the dose has not been stabilized for at least 3 months * Use of AN2728 in a previous clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle | Day 42 | 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 indicates more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (2% twice daily) treated plaque versus (vs.) vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (2% twice daily) treated plaque respectively at Day 42 are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle | Day 42 | 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 scores indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque versus vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque respectively at Day 42 are reported. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator. | 36 |
| AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily AN2728 ointment B 0.5 percent and ointment B vehicle was 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. | 37 |
| AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator. | 35 |
| AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily AN2728 ointment B 2 percent and ointment B vehicle was 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. | 37 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 | 1 | 2 |
| Overall Study | Other | 0 | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily | AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily | AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily | AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 5 Participants | 1 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 31 Participants | 34 Participants | 33 Participants | 134 Participants |
| Gender Female | 6 Participants | 4 Participants | 4 Participants | 4 Participants | 18 Participants |
| Gender Male | 30 Participants | 33 Participants | 31 Participants | 33 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 36 | 14 / 37 | 12 / 34 | 16 / 37 |
| serious Total, serious adverse events | 0 / 36 | 0 / 37 | 0 / 34 | 0 / 37 |
Outcome results
Primary
Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle
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 indicates more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (2% twice daily) treated plaque versus (vs.) vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (2% twice daily) treated plaque respectively at Day 42 are reported.
Time frame: Day 42
Population: Intent-to-treat population included all randomized participants who received study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily | Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle | Ointment Treated Plaque vs. Vehicle Treated Plaque | 54.1 percenatge of participants |
| AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily | Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle | Vehicle Treated Plaque vs. Ointment Treated Plaque | 2.7 percenatge of participants |
p-value: <0.0012-sided sign test
Secondary
Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle
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 scores indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque versus vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque respectively at Day 42 are reported.
Time frame: Day 42
Population: Intent-to-treat population included all randomized participants who received the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily | Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle | Ointment Treated Plaque vs. Vehicle Treated Plaque | 30.6 percenatge of participants |
| AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily | Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle | Vehicle Treated Plaque vs. Ointment Treated Plaque | 11.1 percenatge of participants |
| AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily | Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle | Ointment Treated Plaque vs. Vehicle Treated Plaque | 43.2 percenatge of participants |
| AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily | Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle | Vehicle Treated Plaque vs. Ointment Treated Plaque | 8.1 percenatge of participants |
| AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily | Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle | Ointment Treated Plaque vs. Vehicle Treated Plaque | 40.0 percenatge of participants |
| AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily | Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle | Vehicle Treated Plaque vs. Ointment Treated Plaque | 0.0 percenatge of participants |