Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis

NCT01029405 | Completed Phase 2 Results

• 2 other identifiers: AN2728-PSR-203C3291016
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 5

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

Conditions

Psoriasis

Keywords

Topical; Plaque type psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 42

Secondary Outcomes (1)

• Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle

  Day 42

Study Arms (5)

1. AN2728 Ointment B

ACTIVE COMPARATOR

2%, administered twice daily

Drug: AN2728

2. AN2728 Ointment B Vehicle

PLACEBO COMPARATOR

Drug: Placebo

3. AN2728 Ointment B

ACTIVE COMPARATOR

2%, administered once daily

Drug: AN2728

4. AN2728 Ointment B

ACTIVE COMPARATOR

0.5%, administered twice daily

Drug: AN2728

5. AN2728 Ointment B

ACTIVE COMPARATOR

0.5%, administered once daily

Drug: AN2728

Interventions

AN2728 DRUG

Ointment B, 2% or 0.5% applied once or twice daily

1. AN2728 Ointment B; 3. AN2728 Ointment B; 4. AN2728 Ointment B; 5. AN2728 Ointment B

Placebo DRUG

Ointment B Vehicle applied once or twice daily

2. AN2728 Ointment B Vehicle

Eligibility Criteria

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

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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)
• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Unknown Facility

Chihuahua City, Chihuahua, Mexico

Location

Unknown Facility

Mexico City, D.f., Mexico

Location

Unknown Facility

Zapopan, Jalisco, Mexico

Location

Unknown Facility

Monterrey, Nuevo León, Mexico

Location

Unknown Facility

San Luis Potosí City, San Luis Potosí, Mexico

Location

MeSH Terms

Conditions

Psoriasis

Interventions

crisaborole

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 10, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 7, 2017
• Results First Posted: March 7, 2017

Record last verified: 2017-01

Locations

ME (5)