A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis

NCT02193815 | Completed Phase 1 Results

• 2 other identifiers: B53910032014-000068-16
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a vehicle and comparator controlled Proof of Mechanism (PoM) trial to evaluate the effect on psoriasis disease activity and safety of topically applied PF 06263276 in subjects with psoriasis vulgaris.

Conditions

Psoriasis Vulgaris

Keywords

psoriasis; plaque; vulgaris; phase 1; randomized; double-blind; topical; safety

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12

  Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin.

  Day 1 (Baseline), Day 12

Secondary Outcomes (5)

• Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12

  Day 1 (Baseline), Day 12

• Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12

  Day 1 (Baseline), Day 12

• Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8

  Day 1 (Baseline), Day 8

• Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB

  Day 1 (baseline) up to Day 12

• Global Clinical Assessment at Day 1, 8 and 12

  Day 1, Day 8, Day 12

Other Outcomes (3)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs

  Baseline up to 28 days after last study drug administration (Day 21)

• Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern

  Baseline up to Day 12

• Number of Participants With Potentially Clinically Significant Vital Signs Findings

  Baseline up to Day 12

Study Arms (1)

One Arm

EXPERIMENTAL

Study treatments 1-6 Study drug, vehicle, Tofacitinib, vehicle, Daivonex solution and ointment

Drug: PF06263276; Other: Vehicle; Drug: 2%Tofacitinib Ointment; Drug: Daivonex; Drug: Daivonex Ointment

Interventions

PF06263276 DRUG

4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD

One Arm

Vehicle OTHER

Active ingredient-free vehicle to 4% solution

One Arm

2%Tofacitinib Ointment DRUG

Daily Dosage: approximately 4 mg tofacitinib

One Arm

Daivonex DRUG

Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg

One Arm

Daivonex Ointment DRUG

Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg

One Arm

Eligibility Criteria

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

You may qualify if:

• Healthy male and/or female subjects age 18 years and older, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
• Subjects with psoriasis vulgaris in a chronic stable phase and with a plaque area of mild to moderate severity sufficient for six treatment fields located in up to three plaque areas.
• The target lesion(s) should be on the trunk or extremities (excluding palms/soles). Psoriatic lesions on the knees or elbows are not to be used as a target lesion.

You may not qualify if:

• Subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis.
• Treatment with any systemic medications which in the opinion of the investigator might counter or influence the trial aim (including anti psoriasis medications, eg, corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (eg, beta blocker, anti malarial drugs, lithium) or phototherapy/psoralen+UVA (PUVA) within 4 weeks preceding the treatment phase of the trial and during the trial.
• Treatment with any locally acting medications (including anti-psoriasis medications like vitamin D analogues, dithranol) within 4 weeks of the treatment phase.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Bioskin GmbH

Hamburg, 20095, Germany

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Psoriasis; Plaque, Amyloid

Interventions

PF-06263276; calcipotriene

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

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 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 18, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 9, 2016
• Results First Posted: June 9, 2016

Record last verified: 2016-05

Locations

DE (1)