Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis

NCT03469336 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: C35610012017-002684-18
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

The study is a randomized, double blinded, vehicle and active comparator controlled, multiple dose study in subjects with chronic plaque psoriasis. The study will have approximately 15 completers. Each subjects will receive three different topical doses of PF 06763809, PF 06763809 vehicle, and two active comparators. These will be applied to six different treatment fields for 18 days. The total duration of participation in the study will be approximately 7 weeks (minimum) to approximately 11 weeks (maximum), including the interval from Screening to the Follow up phone call visit.

Conditions

Psoriasis

Keywords

Psoriasis; Topical

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in Psoriatic Skin Infiltrate Thickness

  Baseline was defined to be the measurement on Day 1. MMRM analysis of changes in psoriatic skin in psoriatic skin infiltrate thickness/echo poor band (EPB) in response to PF-06763809 2.3%, 0.8% and 0.23% applied topically for 18 consecutive days as compared to the vehicle control. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.

  Baseline, Days 7, 13 and 19

• Number of Participants With Treatment-emergent Adverse Events (AEs)

  Baseline was defined to be the measurement on Day 1. An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of investigational product.

  Day 1 to Day 49

• Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

  Baseline was defined to be the measurement on Day 1. The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed. Hematology evaluation included: hemoglobin (HGB) (gram per decilitre=g/dL), hematocrit, erythrocytes (Ery.), Ery. Mean Corpuscular Volume, Ery. Mean Corpuscular Hemoglobin, Ery. Mean Corpuscular HGB Concentration (picograms per cell=pg/cell), platelets, leukocytes, lymphocytes, and neutrophils. Clinical chemistry evaluation included: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, creatine kinase, and glucose. Urinalysis evaluation included: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, and leukocyte esterase. LLN=lower limit of normal, ULN=upper limit of normal.

  Day 1 to Day 49

• Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria

  Baseline was defined to be the measurement on Day 1. ECG categorical summarization criteria: 1) PR interval (Value\>=300 milliseconds \[msec\], %Change \[Chg\]\>=25/50%); 2) QRS interval (Value\>=140 msec, \>=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): \>=300 msec, \>=25% change when baseline is \> 200 msec or \>=50% change when baseline is less than or equal to (\<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of \>=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to \<480 msec, 480 to \<500 msec, \>=500 msec; a change from baseline of 30 to \<60 msec or \>=60 msec. The corrected QT interval by Fredericia=QTcF Interval.

  Day 1 to Day 49

• Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria

  Baseline was defined to be the measurement on Day 1. Vital Signs including diastolic blood pressure (DBP), pulse rate, and systolic blood pressure (SBP) were measured.

  Day 1 to Day 49

Secondary Outcomes (3)

• Area Under the Curve of the Psoriatic Skin Infiltrate Thickness

  Day 1 to Day 19

• Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution.

  Baseline, Days 7, 13 and 19

• Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution.

  Baseline, Days 7, 13 and 19

Study Arms (1)

All subjects

OTHER

All subjects will receive all six interventions/treatments applied to six different treatment fields.

Drug: PF-06763809; Other: Vehicle; Drug: Calcipotriene/calcipotriol; Drug: Betamethasone

Interventions

PF-06763809 DRUG

Three different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23%

All subjects

Vehicle OTHER

Vehicle matching PF-06763809.

All subjects

Calcipotriene/calcipotriol DRUG

Calcipotriene/calcipotriol 50 ug/mL solution

All subjects

Betamethasone DRUG

Betamethasone 1 mg/g solution

All subjects

Eligibility Criteria

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

You may qualify if:

• 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
• Target lesion(s) should be on the trunk or extremities (excluding palms/soles).

You may not qualify if:

• History of skin sensitivity to topical prescription or non prescription products such as creams, lotions and cosmetics
• Psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, and pustular psoriasis
• Treatment with any biologics within 3 months prior to Day 1 of the study and during the study

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Rothaar Studien GmbH

Berlin, 10783, Germany

Location

bioskin GmbH

Hamburg, 20095, Germany

Location

Related Publications (1)

• Berstein G, Zhang Y, Berger Z, Kieras E, Li G, Samuel A, Yeoh T, Dowty H, Beaumont K, Wigger-Alberti W, von Mackensen Y, Kroencke U, Hamscho R, Garcet S, Krueger JG, Banfield C, Oemar B. A phase I, randomized, double-blind study to assess the safety, tolerability and efficacy of the topical RORC2 inverse agonist PF-06763809 in participants with mild-to-moderate plaque psoriasis. Clin Exp Dermatol. 2021 Jan;46(1):122-129. doi: 10.1111/ced.14412. Epub 2020 Sep 14.

  PMID: 32767679 DERIVED

Related Links

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

MeSH Terms

Conditions

Psoriasis

Interventions

pf-06763809; calcipotriene; Betamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

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: NONE
• Masking Details: This study is a single arm multi-intervention study. The interventions are masked to participant, investigator, providers and assessors.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 19, 2018
• Study Start: April 24, 2018
• Primary Completion: March 20, 2019
• Study Completion: March 20, 2019
• Last Updated: June 25, 2020
• Results First Posted: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)