A Phase 2 interventional study of Lebrikizumab in Prurigo Nodularis (PN), sponsored by University of Maryland, Baltimore. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of Maryland, Baltimore · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN).
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.
38 studies on the registry are indexed under Prurigo; 10 are open to participants now.
This study's planned enrollment of 15 is below the median of 135 across 31 interventional studies indexed under Prurigo.
Browse Prurigo studies →University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive subcutaneous injections of Lebrikizumab
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.
Also known as: Ebglyss
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.
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
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)
Time frame: Baseline; Week 24
Percentage of subjects achieving at least a 4-point reduction from baseline in weekly average 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.
Time frame: Baseline; Week 24
Percent change from baseline in Dermatology Life Quality Index (DLQI) scores at 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.
Time frame: Baseline; Week 24
Percent change from baseline in The Sleep Disturbance Numerical Rating Scale (SD-NRS) at 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.
Time frame: Baseline; Week 24
Percent change from baseline in 5D-Pruritus Scale at 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.
Time frame: Baseline; Week 24
Percent change from baseline in Prurigo Activity Score (PAS) at 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.
Time frame: Baseline; Week 24
Percent change from baseline in HADS anxiety and depression scale at 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.
Time frame: Baseline; Week 24
Percent change from baseline in Patient Global Impression of Change (PGIC) at 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.
Time frame: Baseline; Week 24
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lebrikizumab
University of Maryland, Baltimore →