Prurigo NodularisPhase 4NCT06773403
Upadacitinib for Prurigo Nodularis
A Phase 4 study testing Upadacitinib in people with Prurigo Nodularis, run by Psoriasis Treatment Center of Central New Jersey at 1 site in United States.
Trial summary
A single center, open-label study of 25 subjects to assess 24 weeks upadacitinib in patients with moderate-to-severe prurigo nodularis. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Prurigo Nodularis
- What is being tested?
- Upadacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2024to 6 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female adult 18-64 years of age at time of screening.
- Diagnosis of prurigo nodularis for ≥ 3 months.
- Moderate-to-Severe prurigo nodularis as determined by at least 10 PN lesions on legs and/or arms and/or trunk at screening and baseline .
- Failure of at least a 2-week course of medium to super potent TCS or TCS is not medically advisable for subject.
- Females of childbearing potential must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at the Baseline Visit prior to study drug dosing. Note: subjects with borderline pregnancy test at Screening must have a serum pregnancy test ≥ 3 days later to determine eligibility.
- If female, subject must be postmenopausal OR permanently surgically sterile OR for females of childbearing potential practicing at least one protocol specified method of birth control, that is effective from the Baseline Visit through at least 30 days after the last dose of study drug. Female subject must not be pregnant, breastfeeding or considering becoming pregnant during the study or for approximately 30 days after the last dose of the study drug.
Show all 9Show fewer
- Subject is a candidate for systemic therapy per investigator discretion.
- Able and willing to give written informed consent prior to performance of any study-related procedures.
- Subject must be in general good health as judged by the Investigator, based on medical history, physical examination.
Who cannot join
- Presence of skin condition other than prurigo nodularis or atopic dermatitis that may interfere with study assessments.
- Diagnosis of active atopic dermatitis at screening and baseline.
- PN secondary to medications.
- PN secondary to medical conditions such as neuropathy or psychiatric disease.
- Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the patient's participation in the study.
- Severe renal conditions (eg, patients with uremia and/or on dialysis)
Show all 12Show fewer
- Participants with uncontrolled thyroid disease.
- Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated. Patients with latent TB at screening may be enrolled if tuberculosis treatment is initiated prior to first dose.
- Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization.
- Active chronic or acute infection (except HIV infection) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit or during the screening period.
- Known or suspected immunodeficiency.
- Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eczema Treatment Center of New Jersey
East Windsor, New Jersey, 08520
About this study
Official title: A 24 Week, Open-Label Study to Evaluate the Efficacy and Safety of Upadacitinib in Patients With Moderate-to-Severe Prurigo Nodularis
A single center, open-label study of 25 subjects to assess 24 weeks upadacitinib in patients with moderate-to-severe prurigo nodularis.
- Conditions
- Prurigo Nodularis
- Being tested
- Upadacitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
All subject start on 15mg. At week 8 subjects may increase to 30mg if the investigators deems it necessary.
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib | Other | Open-label use of 15mg upadacitinib. Subjects have the option to increase to 30mg at week 8 if the investigator deems it necessary. Receives: Drug: Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in worst-itch numeric rating scale (WI-NRS) at week 12
Proportion of participants with improvement (change) in worst-itch numeric rating scale (WI-NRS) by ≥4 points from baseline to Week 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start9 Apr 2024
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Why it stopped: There was not a big enough patient population to meet recruitment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prurigo NodularisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psoriasis Treatment Center of Central New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773403
- Sponsor's protocol ID
- ETC03
- Status last verified
- May 2026
- First submitted
- 8 Jan 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Week, Open-Label Study to Evaluate the Efficacy and Safety of Upadacitinib in Patients With Moderate-to-Severe Prurigo Nodularis
- ClinicalTrials.gov ID
- NCT06773403
- Acronym / sponsor ID
- ETC03
- Conditions
- Prurigo Nodularis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was not a big enough patient population to meet recruitment goals
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Psoriasis Treatment Center of Central New JerseyUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 14 Jan 2025 (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.
A single center, open-label study of 25 subjects to assess 24 weeks upadacitinib in patients with moderate-to-severe prurigo nodularis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib | Other | Drug: UpadacitinibOpen-label use of 15mg upadacitinib. Subjects have the option to increase to 30mg at week 8 if the investigator deems it necessary. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female adult 18-64 years of age at time of screening.
- Diagnosis of prurigo nodularis for ≥ 3 months.
- Moderate-to-Severe prurigo nodularis as determined by at least 10 PN lesions on legs and/or arms and/or trunk at screening and baseline .
- Failure of at least a 2-week course of medium to super potent TCS or TCS is not medically advisable for subject.
- Females of childbearing potential must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at the Baseline Visit prior to study drug dosing. Note: subjects with borderline pregnancy test at Screening must have a serum pregnancy test ≥ 3 days later to determine eligibility.
Key exclusion criteria (12 listed)
- Presence of skin condition other than prurigo nodularis or atopic dermatitis that may interfere with study assessments.
- Diagnosis of active atopic dermatitis at screening and baseline.
- PN secondary to medications.
- PN secondary to medical conditions such as neuropathy or psychiatric disease.
- Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the patient's participation in the study.
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 |
|---|---|---|
| UpadacitinibAll subject start on 15mg. At week 8 subjects may increase to 30mg if the investigators deems it necessary. | Drug | Upadacitinib |
Primary outcome
Reduction in worst-itch numeric rating scale (WI-NRS) at week 12
Time frame: 12 weeks
Proportion of participants with improvement (change) in worst-itch numeric rating scale (WI-NRS) by ≥4 points from baseline to Week 12.
Results and safety
The study was stopped early (reason given: There was not a big enough patient population to meet recruitment goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
Related trials for Prurigo Nodularis
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Prurigo Nodularis.
Prurigo Nodularis (PN)
RecruitingPhase 3
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
Prurigo Nodularis
RecruitingPhase 2
Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis
Prurigo Nodularis (PN)
RecruitingObservational study
Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults
Prurigo Nodularis
Not yet recruitingPhase 2
Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients
Prurigo Nodularis (PN)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Upadacitinib in people with Prurigo Nodularis, run by Psoriasis Treatment Center of Central New Jersey 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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 20 May 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: There was not a big enough patient population to meet recruitment goals). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in worst-itch numeric rating scale (WI-NRS) at week 12 (time frame: 12 weeks). 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 20 May 2026.