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

NCT07620561 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: J2T-NS-X002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prurigo Nodularis (PN)

Keywords

prurigo nodularis; prurigo; lebrikizumab; ebglyss; itch; pruritus; dermatitis; skin diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Percentage of subjects achieving at least a 4-point reduction from baseline in weekly average PP-NRS at Week 24

  Baseline; Week 24

• Percent change from baseline in Dermatology Life Quality Index (DLQI) scores at week 24

  Baseline; Week 24

• Percent change from baseline in The Sleep Disturbance Numerical Rating Scale (SD-NRS) at week 24

  Baseline; Week 24

• Percent change from baseline in 5D-Pruritus Scale at week 24

  Baseline; Week 24

• Percent change from baseline in Prurigo Activity Score (PAS) at week 24

  Baseline; Week 24

Study Arms (1)

Lebrikizumab

EXPERIMENTAL

Participants will receive subcutaneous injections of Lebrikizumab

Drug: Lebrikizumab

Interventions

Lebrikizumab DRUG

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.

Also known as: Ebglyss

Lebrikizumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

UM Dermatology at UM Professional Building

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Prurigo; Pruritus; Dermatitis; Skin Diseases

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristin L Khan, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon J Mangracina, MA

CONTACT

732-757-5831; bmangracina@som.umaryland.edu

Marie Vidaver, PhD

CONTACT

410-685-1726; MVidaver@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

US (1)