Trials Sponsors Conditions Drugs Pricing

Conditions

Prurigo Nodularis (PN)

Keywords

prurigo nodularisprurigolebrikizumabebglyssitchpruritusdermatitisskin 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
+2 more secondary outcomes

Study Arms (1)

Lebrikizumab

EXPERIMENTAL

Participants will receive subcutaneous injections of Lebrikizumab

Drug: Lebrikizumab

Interventions

LebrikizumabDrug

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18-80
Diagnosis of Prurigo Nodularis (PN) for at least 1 year

Sponsors & Collaborators

University of Maryland, Baltimore
Otherlead
Eli Lilly and Company
Industrycollaborator

Study Sites (1)

UM Dermatology at UM Professional Building

Baltimore, Maryland, 21201, United States

Brandon J Mangracina, MACONTACT732-757-5831 bmangracina@som.umaryland.edu

Marie Vidaver, PhDCONTACT410-685-1726 MVidaver@som.umaryland.edu

Kristin L Khan, MDPRINCIPAL INVESTIGATOR

Carolyn Stolte, CRNPSUB INVESTIGATOR

MeSH Terms

Conditions

PrurigoPruritusDermatitisSkin Diseases

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological 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

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

September 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 2027

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (1)

Lebrikizumab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (1)

Lebrikizumab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations