Competitive Research Grant: How does lebrikizumab impact post-inflammatory dyspigmentation as measured by the PDCA-Derm™ scale in patients with moderate to severe atopic dermatitis?-
Lilly Immunology is committed to improving the lives of individuals living with immunological diseases and disorders. We are driven to developing innovative solutions through our broad portfolio of therapeutic agents directed at multiple targets in cytokine pathways. Through internal research programs and support of investigator initiated studies, we are dedicated to long-term partnerships that will enable us to make a real impact on individuals’ lives. Lilly is also committed to support external research in Dermatological clinical and molecular aspects affecting patients with skin of color.
AREA OF INTEREST AND PROJECT TYPES
Projects eligible for support will focus on using the PDCA-Derm™ scale to assess lebrikizumab monotherapy effectiveness in improving post-inflammatory dyspigmentation and related quality of life measures in patients who are initiating lebrikizumab treatment. Projects are encouraged to include patients with all Fitzpatrick skin phototypes.
Projects should address a knowledge gap and avoid overlapping with ongoing or previously published studies using lebrikizumab.
Lilly is dedicated to promoting diversity in clinical trials and establishing clear, measurable goals to drive progress.
Project types may include, but are not limited to:
• Description of post-inflammatory improvements with PDCA Derm
• Evaluation of post-inflammatory changes with novel imaging methods
• Description of patient-reported outcomes and improvements in quality of life related to post-inflammatory dyspigmentation
• Photographic and clinical documentation of clinical improvements
Studies comparing lebrikizumab with other therapies are out of scope. Interventional and noninterventional trials will be taken into consideration.
FUNDING RANGE AND PROJECT LENGTH
Up to approximately $500,000 – Project length can be up to two years.
• Award amounts include all direct costs, institutional overhead, and indirect costs.
• Grants will be distributed following a fully executed agreement and will be based on milestones/enrollment and a final report.
• Placebo will NOT be provided for research.
PIRA™ proposals are AI generated and are not reviewed or endorsed by the sponsoring company.
Competitive Clinical Research Grant Proposal
Sponsor: Eli Lilly and Company
Study Drug: Lebrikizumab (LY3650150)
Focus Area: Post-Inflammatory Dyspigmentation in Atopic Dermatitis using PDCA-Derm™ Scale
Investigator Information
Name: ___________________________
Institution: ___________________________
Address: ___________________________
Phone: ___________________________
Email: ___________________________
Are you a physician? ☐ Yes ☐ No
Medical License Number: ___________________________
Proposal Title
“Evaluating the Impact of Lebrikizumab on Post-Inflammatory Dyspigmentation in Atopic Dermatitis Using the PDCA-Derm™ Scale: A Prospective, Real-World Study Across Diverse Skin Phototypes”
Objective
The primary goal of this study is to evaluate the effectiveness of lebrikizumab monotherapy in improving post-inflammatory dyspigmentation among patients with moderate-to-severe atopic dermatitis (AD) using the PDCA-Derm™ scale. The study also aims to assess the correlation between PDCA-Derm™ improvements, patient-reported quality-of-life outcomes, and skin phototype diversity (Fitzpatrick I–VI).
Primary and Secondary Endpoints
Primary Endpoint:
- Mean change in PDCA-Derm™ total score from baseline to Week 16 and Week 24 following lebrikizumab initiation.
Secondary Endpoints:
- Changes in patient-reported quality of life (DLQI, POEM).
• Correlation between PDCA-Derm™ score improvements and EASI response.
• Photographic and clinical documentation of dyspigmentation improvement.
• Stratified analysis by Fitzpatrick phototype to evaluate response across skin tones.
Rationale
Post-inflammatory dyspigmentation (PID) is a common and distressing sequela of atopic dermatitis, particularly in patients with darker skin tones (Fitzpatrick IV–VI). While biologic therapies such as lebrikizumab have demonstrated efficacy in reducing inflammation and restoring skin barrier function, their specific impact on residual pigmentary alterations remains understudied. The PDCA-Derm™ scale offers a standardized and validated tool for quantifying dyspigmentation severity and treatment response. This study seeks to address a critical knowledge gap by providing real-world data on pigment restoration, patient satisfaction, and the role of IL-13 blockade in post-inflammatory pigmentation recovery.
Patient Population
The study will enroll approximately 100 adults (≥18 years) diagnosed with moderate-to-severe atopic dermatitis who are initiating lebrikizumab monotherapy. Participants will represent all Fitzpatrick skin phototypes (I–VI), with targeted recruitment to ensure adequate representation of skin-of-color populations (≥40%).
Project Design and Methods
This is a multicenter, prospective, observational study conducted over 24 weeks. Patients initiating lebrikizumab as standard of care will be assessed using the PDCA-Derm™ scale at baseline, Week 8, Week 16, and Week 24. Clinical photography will be standardized under controlled lighting conditions. Quality-of-life instruments (DLQI, POEM) and EASI scores will be collected in parallel. Subgroup analyses will explore pigment improvement patterns by age, sex, and phototype.
Evaluation and Outcomes
Efficacy assessments will be performed at Weeks 8, 16, and 24 using PDCA-Derm™ scores, investigator global assessment (IGA), EASI, DLQI, and POEM. Safety assessments will include monitoring for adverse events consistent with lebrikizumab’s known profile. Outcomes will be analyzed using mixed-model repeated measures and correlation analyses for PDCA-Derm™ and QoL improvements.
Anticipated Project Timeline
- Project Start: May 1, 2026
• Enrollment Period: May–October 2026
• Final Visit / Data Lock: April 2027
• Data Analysis and Manuscript Preparation: May–August 2027
• Publication and Presentation: Fall 2027
Grant Requested
$450,000 (inclusive of direct and indirect costs, institutional overhead, and milestone-based payments).
Expected Impact
This project will provide the first prospective, PDCA-Derm™–based dataset evaluating the pigmentary and psychosocial benefits of IL-13 inhibition in AD. The findings are expected to enhance clinician awareness of pigment outcomes, improve patient education regarding dyspigmentation recovery, and advance diversity-focused