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NCT05879718 · ClinicalTrials.gov registry record · Phase 2
A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
A Phase 2 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT05879718: Clinical Trial Phase 2 study, sponsored by Pfizer.
NCT05879718 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05879718, a Phase 2 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study 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 involvement of the skin. * have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score of 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 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.
Primary Outcome
Change from baseline GS was calculated as GS(t) - GS(0), where GS(t) was the gene signature score at Week 12 and GS(0) was the gene signature score at Baseline, where the GS(t) was calculated as the mean of log2 transformed counts per million reads from each of 13 genes in RNAseq, the higher GS indicated coordinated higher expression. There is no minimum/maximum limit to the GS score. Gene expression was quantified using RNA sequencing and summarized as log2-transformed counts per million mapped
Interventions
- DRUG Placebo
- DRUG PF-06823859
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-07-07 |
| Est. Completion | 2025-11-18 |
| Phase | Phase 2 |
Why NCT05879718 stopped before completion
NCT05879718 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05879718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05879718 about?
NCT05879718 is a clinical study titled "A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.". 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...
What is the current status of trial NCT05879718?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2023-07-07. Estimated completion is 2025-11-18.
What interventions are being tested in trial NCT05879718?
The interventions under investigation include: Placebo (DRUG), PF-06823859 (DRUG).
Who is sponsoring clinical trial NCT05879718?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05879718's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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