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Not yet recruiting NCT07620561

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

Phase II Interventional Prurigo Nodularis (PN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lebrikizumab.
Who it may be relevant to
Registry conditions: Prurigo Nodularis (PN). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

  • 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.

Primary outcome measures

  • Percent change from baseline in weekly average Peak Pruritus Numeric Rating Scale (PP-NRS) at week 24 [Time frame: Baseline; Week 24]
  • Percentage of patients achieving an Investigator Global Assessment for Prurigo Nodularis Stage (IGA PN-S) score of 0 or 1 [Time frame: Baseline; Week 24]
Secondary outcome measures (7)
  • Percentage of subjects achieving at least a 4-point reduction from baseline in weekly average PP-NRS at Week 24 [Time frame: Baseline; Week 24]
  • Percent change from baseline in Dermatology Life Quality Index (DLQI) scores at week 24 [Time frame: Baseline; Week 24]
  • Percent change from baseline in The Sleep Disturbance Numerical Rating Scale (SD-NRS) at week 24 [Time frame: Baseline; Week 24]
  • Percent change from baseline in 5D-Pruritus Scale at week 24 [Time frame: Baseline; Week 24]
  • Percent change from baseline in Prurigo Activity Score (PAS) at week 24 [Time frame: Baseline; Week 24]
  • Percent change from baseline in HADS anxiety and depression scale at week 24 [Time frame: Baseline; Week 24]
  • Percent change from baseline in Patient Global Impression of Change (PGIC) at week 24 [Time frame: Baseline; Week 24]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • UM Dermatology at UM Professional Building — Baltimore

Identifiers

NCT: NCT07620561 · J2T-NS-X002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗