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C0251013 - 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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503343-33-00
Acronym
C0251013
Enrollment
10
Registered
2023-10-02
Start date
2023-12-21
Completion date
2025-10-08
Last updated
2025-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Cutaneous Lupus Erythematosus (CLE) or Systemic Lupus Erythematosus (SLE) With Cutaneous Manifestations

Brief summary

Change from baseline in type 1 IFN GS score in lesional skin at Week 12

Detailed description

Change from baseline (%) in CLASI A score at Week 12, Percent change from baseline in CLASI-A (over time in addition to Week 12). Change from baseline in CLASI-A (over time). Achieving ≥50%, 4 or 7 points reduction in CLASI-A (over time), Change from baseline in PhGA (over time), Incidence and severity of laboratory, vital signs, 12-lead ECG abnormalities, AEs, SAEs and withdrawals due to AEs over time

Interventions

DRUGPF-06823859
DRUGPlacebo for PF-06823859

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in type 1 IFN GS score in lesional skin at Week 12—

Secondary

MeasureTime frame
Change from baseline (%) in CLASI A score at Week 12, Percent change from baseline in CLASI-A (over time in addition to Week 12). Change from baseline in CLASI-A (over time). Achieving ≥50%, 4 or 7 points reduction in CLASI-A (over time), Change from baseline in PhGA (over time), Incidence and severity of laboratory, vital signs, 12-lead ECG abnormalities, AEs, SAEs and withdrawals due to AEs over time—

Countries

Greece, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026