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A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.

Primary Purpose

Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
PF-06823859
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring type 1 IFN gene signature

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Have a histologically confirmed active CLE or SLE with cutaneous manifestations in the form of subacute cutaneous lupus erythematosus or/and discoid/chronic cutaneous lupus erythematosus at least 3 months and CLASI-A at least 8 or higher. Participant has adequate intravenous infusion access per investigator's judgement Willing to comply study procedures including skin punch biopsies procedures. Weight is greater than 40 kg and less than130 kg. Exclusion Criteria: Skin disorders other than CLE or SLE. Active, severe lupus nephritis requiring treatment with cytotoxic agents or high-dose steroids. Active severe central nervous system lupus requiring therapeutic intervention within 60 days of baseline. Cancer or a history of cancer within 5 years of screening except adequately resected cutaneous basal cells, squamous cell carcinoma, or carcinoma in situ of uterine cervix. Known history of a major cardiovascular or cerebrovascular event, pulmonary arterial hypertension, pulmonary embolism within 6 months Have any autoimmune or inflammatory disease that would interfere with interpretation of test results or clinical assessments. History of disseminated herpes zoster or disseminated herpes simplex or recurrent localized, dermatomal herpes zoster. Serious infection within 60 days of baseline or an active infection treated with oral anti-biotics within 14 days of baseline. Have evidence of active or latent infection of hepatitis B or C, known history of human immunodeficient virus (HIV) infection, or infected with Mycobacterium TB without adequately treatment Laboratory abnormalities meet exclusion criteria at the Screening visit. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • DermEffectsRecruiting
  • Oshawa Clinic Dermatology Trials
  • Dermatology on Bloor - Research Toronto
  • Alpha Recherche Clinique
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

PF-06823859

Placebo

Outcomes

Primary Outcome Measures

Change from baseline in type 1 IFN GS score in lesional skin at Week 12
A 13-gene IFN gene signature score was used to measure IFN activity at both baseline and week 12, the gene signature score is assessed per sample by averaging the log2CPM(Counts Per Million reads) values of these 13 genes through RNAseq profiling. The gene signature score is positively linked to the gene expression activity of those 13 genes that are related to IFN.

Secondary Outcome Measures

Percent change from baseline in CLASI-A score at Week 12
The Cutaneous Erythematosus Disease Area and Severity Index (CLASI) is a clinician rated scale composed of 56 items designed to assess the disease activity and damage in CLE in adults. The disease activity (CLASI-A) sub-score ranges from 0 to 70: 0-9 indicating mild disease, 10-20 indicating moderate disease, and 21-70 indicating severe disease.
Percent change from baseline in CLASI-A (over time in addition to Week 12)
Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 4 and Week 8
Change from baseline in CLASI-A score at Week 12
Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 4, 8 and 12
Achieving ≥50%, 4 or 7 points reduction in CLASI-A (over time)
Achieving ≥50%, 4 or 7 points reduction in CLASI-A at Week 4, 8 and 12
Change from baseline in Physician global assessment (PhGA) (over time)
The PhGA is a visual analog scale (VAS) tool to measure worsening in the participant general health status. Physician will place a mark on the scale between 0 (none), 1 (mild), 2(moderate) and 3 (severe).
Incidence and severity of laboratory, vital signs, 12-lead ECG abnormalities, AEs, SAEs and withdrawals due to AEs over time

Full Information

First Posted
May 18, 2023
Last Updated
September 15, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05879718
Brief Title
A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
Official Title
A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE CLINICAL EFFECT, PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY PROFILE OF PF-06823859 IN ADULT PARTICIPANTS WITH ACTIVE CLE OR SLE WITH CUTANEOUS MANIFESTATIONS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2023 (Actual)
Primary Completion Date
December 17, 2025 (Anticipated)
Study Completion Date
November 18, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms. This study is seeking for participants who: are adults of 18 years of age or older. are confirmed to have CLE or SLE with some symptoms of the skin. have a cutaneous LE disease area and severity index activity (CLASI-A) score at least 8. About 48 participants will be selected to receive active study medicine (PF-06823859) or placebo (an infusion without drug). About 32 are grouped to receive the active study medicine and 16 are to receive placebo. They will be receiving the treatments by intravenous infusion (injected directly into the veins). At week 16, participants receiving the active study medicine and non-clinical responders from placebo will receive the active study medicine. The placebo clinical responders will continue to receive placebo till Week 40. All participants will have last follow-up visit at Week 60. The study will compare participants receiving PF-06823859 to participants who receive placebo. This will help us see if PF-06823859 is safe and effective to treat CLE or SLE and improve the CLASI-A score. Participants will take part in this study for about 65 weeks. This includes up to a 5-week selection period, a 12-week start of treatment period, a 36-week long term extension treatment period, and a 12-week follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous
Keywords
type 1 IFN gene signature

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
About 48 eligible participants will be randomized in a 2:1 ratio to receive either PF-06823859 or placebo. Following assessments for the primary endpoint at Week 12, participants who are receiving active PF-06823859 or who are placebo non responders (responder is defined by ≥4 point reduction from the baseline in CLASI-A score) will receive PF-06823859 beginning at Week 16, while placebo responders will continue to be in the placebo group. The last dose of study intervention will be administered at Week 40 followed by last full study assessments at Week 48. The follow up visit will be conducted at Week 60.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
PF-06823859
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (intravenous infusion)
Intervention Type
Drug
Intervention Name(s)
PF-06823859
Intervention Description
PF-06823859 (intravenous infusion)
Primary Outcome Measure Information:
Title
Change from baseline in type 1 IFN GS score in lesional skin at Week 12
Description
A 13-gene IFN gene signature score was used to measure IFN activity at both baseline and week 12, the gene signature score is assessed per sample by averaging the log2CPM(Counts Per Million reads) values of these 13 genes through RNAseq profiling. The gene signature score is positively linked to the gene expression activity of those 13 genes that are related to IFN.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percent change from baseline in CLASI-A score at Week 12
Description
The Cutaneous Erythematosus Disease Area and Severity Index (CLASI) is a clinician rated scale composed of 56 items designed to assess the disease activity and damage in CLE in adults. The disease activity (CLASI-A) sub-score ranges from 0 to 70: 0-9 indicating mild disease, 10-20 indicating moderate disease, and 21-70 indicating severe disease.
Time Frame
Week 12
Title
Percent change from baseline in CLASI-A (over time in addition to Week 12)
Description
Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 4 and Week 8
Time Frame
Week 4 and Week 8
Title
Change from baseline in CLASI-A score at Week 12
Description
Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 4, 8 and 12
Time Frame
Week 4, 8, and 12
Title
Achieving ≥50%, 4 or 7 points reduction in CLASI-A (over time)
Description
Achieving ≥50%, 4 or 7 points reduction in CLASI-A at Week 4, 8 and 12
Time Frame
Week 4, 8, 12
Title
Change from baseline in Physician global assessment (PhGA) (over time)
Description
The PhGA is a visual analog scale (VAS) tool to measure worsening in the participant general health status. Physician will place a mark on the scale between 0 (none), 1 (mild), 2(moderate) and 3 (severe).
Time Frame
Week 4, 8 and 12
Title
Incidence and severity of laboratory, vital signs, 12-lead ECG abnormalities, AEs, SAEs and withdrawals due to AEs over time
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a histologically confirmed active CLE or SLE with cutaneous manifestations in the form of subacute cutaneous lupus erythematosus or/and discoid/chronic cutaneous lupus erythematosus at least 3 months and CLASI-A at least 8 or higher. Participant has adequate intravenous infusion access per investigator's judgement Willing to comply study procedures including skin punch biopsies procedures. Weight is greater than 40 kg and less than130 kg. Exclusion Criteria: Skin disorders other than CLE or SLE. Active, severe lupus nephritis requiring treatment with cytotoxic agents or high-dose steroids. Active severe central nervous system lupus requiring therapeutic intervention within 60 days of baseline. Cancer or a history of cancer within 5 years of screening except adequately resected cutaneous basal cells, squamous cell carcinoma, or carcinoma in situ of uterine cervix. Known history of a major cardiovascular or cerebrovascular event, pulmonary arterial hypertension, pulmonary embolism within 6 months Have any autoimmune or inflammatory disease that would interfere with interpretation of test results or clinical assessments. History of disseminated herpes zoster or disseminated herpes simplex or recurrent localized, dermatomal herpes zoster. Serious infection within 60 days of baseline or an active infection treated with oral anti-biotics within 14 days of baseline. Have evidence of active or latent infection of hepatitis B or C, known history of human immunodeficient virus (HIV) infection, or infected with Mycobacterium TB without adequately treatment Laboratory abnormalities meet exclusion criteria at the Screening visit. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
DermEffects
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Oshawa Clinic Dermatology Trials
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 1B9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Dermatology on Bloor - Research Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C0251013
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.

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