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

31 augusti 2026 uppdaterad av: Kristin Khan, University of Maryland, Baltimore

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).

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

15

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21201
        • UM Dermatology at UM Professional Building
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Kristin L Khan, MD
        • Underutredare:
          • Carolyn Stolte, CRNP

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Lebrikizumab
Participants will receive subcutaneous injections of Lebrikizumab
Läkemedel: 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.
Andra namn:
  • Ebglys

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percent change from baseline in weekly average Peak Pruritus Numeric Rating Scale (PP-NRS) at week 24
Tidsram: 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.
Baseline; Week 24
Percentage of patients achieving an Investigator Global Assessment for Prurigo Nodularis Stage (IGA PN-S) score of 0 or 1
Tidsram: 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)
Baseline; Week 24

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of subjects achieving at least a 4-point reduction from baseline in weekly average PP-NRS at Week 24
Tidsram: 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.
Baseline; Week 24
Percent change from baseline in Dermatology Life Quality Index (DLQI) scores at week 24
Tidsram: 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.
Baseline; Week 24
Percent change from baseline in The Sleep Disturbance Numerical Rating Scale (SD-NRS) at week 24
Tidsram: 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.
Baseline; Week 24
Percent change from baseline in 5D-Pruritus Scale at week 24
Tidsram: 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.
Baseline; Week 24
Percent change from baseline in Prurigo Activity Score (PAS) at week 24
Tidsram: 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.
Baseline; Week 24
Percent change from baseline in HADS anxiety and depression scale at week 24
Tidsram: 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.
Baseline; Week 24
Percent change from baseline in Patient Global Impression of Change (PGIC) at week 24
Tidsram: 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.
Baseline; Week 24

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Maryland, Baltimore

Samarbetspartners

Eli Lilly and Company

Utredare

  • Huvudutredare: Kristin L Khan, MD, University of Maryland, Baltimore

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 december 2027

Avslutad studie (Beräknad)

1 mars 2028

Studieregistreringsdatum

Först inskickad

26 maj 2026

Först inskickad som uppfyllde QC-kriterierna

26 maj 2026

Första postat (Faktisk)

2 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 augusti 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • J2T-NS-X002

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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