Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07620561

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Prurigo Nodularis (PN) Dermatitis Pathological Conditions, Signs and Symptoms Prurigo Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UM Dermatology at UM Professional Building

Baltimore, Maryland, 21201, United States

Location contact

Brandon J Mangracina, MA

CONTACT

[email protected]

732-757-5831

Carolyn Stolte, CRNP

SUB_INVESTIGATOR

Kristin L Khan, MD

PRINCIPAL_INVESTIGATOR

Marie Vidaver, PhD

CONTACT

[email protected]

410-685-1726

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Ebglyss

Primary outcomes

  1. Percent change from baseline in weekly average Peak Pruritus Numeric Rating Scale (PP-NRS) at week 24

    Time frame: Baseline; 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.

  2. 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

    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)

Secondary outcomes

  1. 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

    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.

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

    Time frame: Baseline; 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.

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

    Time frame: Baseline; 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.

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

    Time frame: Baseline; 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.

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

    Time frame: Baseline; 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.

  6. Percent change from baseline in HADS anxiety and depression scale at week 24

    Time frame: Baseline; 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.

  7. Percent change from baseline in Patient Global Impression of Change (PGIC) at week 24

    Time frame: Baseline; 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brandon J Mangracina, MA

CONTACT

[email protected]

732-757-5831

Marie Vidaver, PhD

CONTACT

[email protected]

410-685-1726

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.