Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients

Evaluating the Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients: A 24-Week Study

The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN).

Study Overview

• Status: Not yet recruiting
• Conditions: Prurigo Nodularis (PN)
• Intervention / Treatment: Drug: Lebrikizumab

Detailed Description

This study is a Phase II, single center, open-label, single-arm clinical trial. Study participation will last up to 32 weeks, including a 4-week screening period, a 24-week treatment period with all participants receiving lebrikizumab injections, and a 4-week safety follow up period.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Brandon J Mangracina, MA; Phone Number: 732-757-5831; Email: bmangracina@som.umaryland.edu
• Study Contact Backup: Name: Marie Vidaver, PhD; Phone Number: 410-685-1726; Email: MVidaver@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • UM Dermatology at UM Professional Building
      • Contact: Brandon J Mangracina, MA; Phone Number: 732-757-5831; Email: bmangracina@som.umaryland.edu
      • Contact: Marie Vidaver, PhD; Phone Number: 410-685-1726; Email: MVidaver@som.umaryland.edu
      • Principal Investigator: Kristin L Khan, MD
      • Sub-Investigator: Carolyn Stolte, CRNP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-80
• Diagnosis of Prurigo Nodularis (PN) for at least 1 year
• Active PN with moderate-to-severe itch, several nodules, and presence of nodules in more than one part of the body
• Women of childbearing potential must agree to remain abstinent or use a highly effective contraceptive method during treatment and for at least 18 weeks after the last dose of study drug
• Male participants must agree to use an effective barrier contraceptive if sexually active with a woman of childbearing potential during treatment and for at least 18 weeks after the last dose of study drug

Exclusion Criteria:

• Prior participation in a lebrikizumab study
• History of anaphylaxis
• History of or active HIV
• Active hepatitis or known liver cirrhosis
• History of cancer in the past 5 years, except for fully treated early cervical cancer in situ or non-melanoma skin cancers (basal cell or squamous cell skin cancer) that have been successfully treated and resolved. This includes certain skin lymphomas such as mycosis fungoides.
• Uncontrolled chronic conditions that may require intermittent oral steroid use, such as severe uncontrolled asthma
• Current or recent parasitic infection
• Immunocompromised individuals
• Pregnant or breastfeeding women or those planning to become pregnant or breastfeed during the study period
• Use of other treatments for PN during the study, such as topical, systemic, or light-based treatments
• Current or recent treatment with biologic drugs
• Use of drugs that have an effect on the immune system during the study and within 4 weeks of starting the study
• Receipt of phototherapy or light-based therapy within 4 weeks before starting the study
• Regular use of tanning booths or parlors within 4 weeks before starting the study
• Receipt of a live vaccine within 12 weeks before starting the study or planned receipt during the study
• Recent use of an experimental drug

Other protocol-defined Inclusion/Exclusion Criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lebrikizumab; Participants will receive subcutaneous injections of Lebrikizumab	Drug: Lebrikizumab; Participants will receive subcutaneous injections of Lebrikizumab every two weeks for 24 weeks. The first two doses will be 500 mg, and following doses will be 250 mg.; Other Names: Ebglyss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change from baseline in weekly average Peak Pruritus Numeric Rating Scale (PP-NRS) at week 24	The PP-NRS is a single-item measure assessing itch on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants will complete the PP-NRS daily, rating their worst level of itch during the past 24 hours.	Baseline; Week 24
Percentage of patients achieving an Investigator Global Assessment for Prurigo Nodularis Stage (IGA PN-S) score of 0 or 1	The percentage of patients achieving an IGA PN-S score of 0 or 1 with a ≥2-point reduction from baseline to Week 24. The IGA PN-S is a rating completed by the investigator during visits assessing the severity of the disease from 0 (Clear) to 4 (Severe)	Baseline; Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects achieving at least a 4-point reduction from baseline in weekly average PP-NRS at Week 24	The PP-NRS is a single-item measure assessing itch on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants will complete the PP-NRS daily, rating their worst level of itch during the past 24 hours.	Baseline; Week 24
Percent change from baseline in Dermatology Life Quality Index (DLQI) scores at week 24	The DLQI is a 10-item questionnaire used to assess the impact of skin disease on the quality of life of the affected person. The 10 questions are scored from 0 to 3, giving a possible total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Completed by participants during study visits specified in the protocol.	Baseline; Week 24
Percent change from baseline in The Sleep Disturbance Numerical Rating Scale (SD-NRS) at week 24	The SD-NRS is a single-item measure assessing sleep disturbance on a scale from 0 ("no sleep disturbance") to 10 ("worst possible sleep disruption"). Participants will complete the SD-NRS daily, rating their sleep quality.	Baseline; Week 24
Percent change from baseline in 5D-Pruritus Scale at week 24	5-D pruritus' scale is a questionnaire assessing duration, degree, direction, disability, and distribution of the affected person's itch. Completed by participants during study visits specified in the protocol.	Baseline; Week 24
Percent change from baseline in Prurigo Activity Score (PAS) at week 24	The PAS is a 7-item assessment completed by the investigator. The items of the PAS evaluate the type, number, distribution, size, and activity of skin lesions.	Baseline; Week 24
Percent change from baseline in HADS anxiety and depression scale at week 24	The Hospital Anxiety and Depression Survey is a questionnaire that evaluates and monitors mental health in adults. Completed by participants during study visits specified in the protocol.	Baseline; Week 24
Percent change from baseline in Patient Global Impression of Change (PGIC) at week 24	The PGIC is a questionnaire assessing overall satisfaction and perceived change due to treatment, ranging from "very much improved" to "very much worse". Completed by participants during study visits specified in the protocol.	Baseline; Week 24

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Kristin L Khan, MD, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pruritus; skin diseases; dermatitis; itch; prurigo; prurigo nodularis; lebrikizumab; ebglyss
• Additional Relevant MeSH Terms: Skin Manifestations; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Dermatitis; Skin Diseases; Pruritus; Prurigo; lebrikizumab
• Other Study ID Numbers: J2T-NS-X002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes