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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503343-33-00 | Registry Identifier | CTIS (EU) |
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Pfizer has made an internal business decision to not continue this study. This decision was not due to safety concerns or clinical effect reasons or requests from any regulatory authorities.
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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:
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 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication. Patients who have received placebo since Day 1 and who have had a clinical response 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 with skin symptoms and improve participant's 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 Q4Wk treatment period, a 36-week Q8Wk treatment period, and a 12-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | PF-06823859 |
|
| Group 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo (intravenous infusion) |
| |
| PF-06823859 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in CLASI-A score at Week 12 | The Cutaneous Lupus Erythematosus Disease Activity and Damage Score | Week 12 |
| Percent change from baseline in CLASI-A (over time in addition to Week 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kirklin Clinic of UAB Hospital | Birmingham | Alabama | 35233 | United States | ||
| University of Alabama at Birmingham - School of Medicine |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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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 final follow up visit will be conducted at Week 60.
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| Drug |
PF-06823859 (intravenous infusion) |
|
Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score
| Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60 |
| Change from baseline in CLASI-A score (over time) | Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score | Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60 |
| Achieving ≥50%, 4 or 7 points reduction in CLASI-A (over time) | Achieving ≥50%, 4 or 7 points reduction in CLASI-A | Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60 |
| 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). | Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60 |
| Incidence and severity of laboratory, vital signs, 12-lead ECG abnormalities, AEs, SAEs and withdrawals due to AEs over time | Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 56, and 60 |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| University of Alabama at Birmingham, Department of Dermatology | Birmingham | Alabama | 35233 | United States |
| The University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States |
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | United States |
| Mayo Clinic in Arizona - Scottsdale | Scottsdale | Arizona | 85259 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| The University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| DermEffects | London | Ontario | N6H 5L5 | Canada |
| Dermatology on Bloor - Research Toronto | Toronto | Ontario | M4W 2N4 | Canada |
| Whitby Health Centre | Whitby | Ontario | L1P 0p9 | Canada |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" | Chaïdári | Attikí | 124 62 | Greece |
| Ionos Dragoumi 5 Kaisariani | Kaisarianí | Attikí | 16121 | Greece |
| Dermatological and Venereological Hospital Andreas Syggros | Athens | 161 21 | Greece |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 3, 2026 | Jun 25, 2026 | 22 |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D008178 | Lupus Erythematosus, Cutaneous |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012871 | Skin Diseases |
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