Prurigo Nodularis (PN)Phase 2NCT07620561
Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients
A Phase 2 study testing Lebrikizumab in people with Prurigo Nodularis (PN), run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prurigo Nodularis (PN)
- What is being tested?
- Lebrikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UM Dermatology at UM Professional Building
Baltimore, Maryland, 21201
Brandon J Mangracina, MA, 732-757-5831, bmangracina@som.umaryland.edu
Marie Vidaver, PhD, 410-685-1726, MVidaver@som.umaryland.edu
About this study
Official title: 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).
Read the 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.
- Conditions
- Prurigo Nodularis (PN)
- Being tested
- Lebrikizumab
- Keywords
- prurigo nodularis, prurigo, lebrikizumab, ebglyss, itch, pruritus, dermatitis, skin diseases
- Medical subject headings
- Prurigo, Pruritus, Dermatitis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LebrikizumabDrug
Also called Ebglyss
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.
| Study group | Role | What they receive |
|---|---|---|
| Lebrikizumab | Experimental | Participants will receive subcutaneous injections of Lebrikizumab Receives: Drug: Lebrikizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prurigo Nodularis (PN)Studies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Kristin Khan, University of Maryland, Baltimore
- Investigators
- Kristin L Khan, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620561
- Sponsor's protocol ID
- J2T-NS-X002
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients: A 24-Week Study
- ClinicalTrials.gov ID
- NCT07620561
- Acronym / sponsor ID
- J2T-NS-X002
- Conditions
- Prurigo Nodularis (PN)
- Keywords
- prurigo nodularis, prurigo, lebrikizumab, ebglyss, itch, pruritus, dermatitis, skin diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lebrikizumab | Experimental | Drug: LebrikizumabParticipants will receive subcutaneous injections of Lebrikizumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LebrikizumabAlso: EbglyssParticipants 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. | Drug | Lebrikizumab |
Primary outcome
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.
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)
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin L Khan, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lebrikizumab in people with Prurigo Nodularis (PN), run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandon J Mangracina, MA (732-757-5831, bmangracina@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in weekly average Peak Pruritus Numeric Rating Scale (PP-NRS) at week 24 (time frame: Baseline; Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.