Prurigo NodularisPhase 2NCT05038982
Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
A Phase 2 study testing Abrocitinib in people with Prurigo Nodularis and Pruritus, run by Johns Hopkins University at 1 site in United States.
Trial summary
The primary objective is to assess the efficacy, safety, and tolerability of Abrocitinib for the treatment of Prurigo Nodularis (PN) or Chronic Pruritus of Unknown Origin (CPUO) in patients experiencing moderate to severe pruritus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prurigo Nodularis, Pruritus, Chronic Pruritus
- What is being tested?
- Abrocitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2021to 11 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males or female participants between ages 18-80 years at time of signing informed consent
- A clinical diagnosis of prurigo nodularis, defined by the presence of at least 10 pruritic nodules on at least 2 different anatomic locations (with each arm, leg, and anterior and posterior trunk considered distinct anatomic locations)
- OR
- Subject has ongoing chronic pruritus of unknown origin, which must be present on multiple segments on the body. CPUO patients must not have known dermatologic or systemic conditions, that in the opinion of the investigator, are the cause of patient's pruritus
- Subject has moderate to severe pruritus, defined as average peak pruritus numeric rating scale - (PP-NRS) > 7 (range 0-10, higher score indicating greater degree of pruritus severity) in the 7 days prior to the Screening Visit.
- Female participants are eligible for the study if they are not pregnant, planning to become pregnant or breastfeeding during the study or not a woman of child bearing potential (WOCBP)
Who cannot join
- Infected with hepatitis B or hepatitis C viruses.
- Infected with Herpes Simplex or Herpes zoster.
- Positive HIV serology at screening,
- Evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- History of lymphoproliferative disease, or active primary or recurrent malignancy
- History of recurrent (≥ 2) venous thromboembolism (VTE) or (DVT/PE) - deep vein thrombosis and pulmonary embolism
Show all 15Show fewer
- Untreated thyroid, adrenal, or pituitary disease or nodules, or history of thyroid malignancy
- Have received any of the following treatment regiments specified in the timeframes outlined below:
- Within 6 months of first dose of study drug: Rituximab, any other B cell depleting therapies, or intravenous immunoglobulin (IVIg)
- Within 12 weeks of first dose of study drug: Any studies with Janus kinase (JAK) inhibitors; Cyclophosphamide (or any other cytotoxic agent), belimumab, or anifrolumab (or another anti-interferon (IFN) therapy)
- Within 8 weeks of first dose of study drug: Other biologics
- Within 6 weeks: Have been vaccinated with live or attenuated live vaccine.
- Within 4 weeks: Participation in other studies involving investigational drug(s)
- Within 4 weeks: Use of oral immune suppressants; systemic immunosuppressive therapies, neuromodulatory therapies, Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.
- Within 1 week of first dose of study drug: Topical treatments that could affect PN; Herbal medications with unknown properties or known beneficial effects for PN.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21205
About this study
Official title: Efficacy, Safety, and Tolerability of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
The primary objective is to assess the efficacy, safety, and tolerability of Abrocitinib for the treatment of Prurigo Nodularis (PN) or Chronic Pruritus of Unknown Origin (CPUO) in patients experiencing moderate to severe pruritus.
Read the detailed description
This is a trial to assess the efficacy of Abrocitinib as a therapeutic for Prurigo Nodularis (PN) and Chronic Pruritus of Unknown Origin (CPUO). The study will consist of a 4-week Screening period, a 12-week treatment period and then a 4-week follow up period. The arms will run in parallel and patients will take 200 mg oral Abrocitinib daily for the duration of the 12-week treatment period.
- Conditions
- Prurigo Nodularis, Pruritus, Chronic Pruritus, Chronic Prurigo, Skin Diseases
- Being tested
- Abrocitinib
- Medical subject headings
- Pruritus, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbrocitinibDrug
During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
| Study group | Role | What they receive |
|---|---|---|
| Prurigo Nodularis | Experimental | Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Receives: Drug: Abrocitinib |
| Chronic Pruritus of Unknown Origin | Experimental | Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Receives: Drug: Abrocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12
Percent change in weekly average PP-NRS at Week 12. PP-NRS is a single self-report item on an 11-point scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable.
Measured: Up to 12 weeks
Secondary outcomes (16)
Number of Subjects Achieving a Reduction in Weekly Average PP-NRS From Baseline to Week 12
Number of subjects achieving at least a 4-point reduction from baseline in weekly average PP-NRS at Week 12. The PP-NRS is a single self-report item on an 11-point scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable.
Measured: Up to 12 weeks
Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12
Assess itch severity as assessed by 5-D pruritus scale. The 5-D pruritus scale scores pruritus over the past 2 weeks along 5 dimensions: duration, degree, direction, disability and distribution. Duration, degree and direction are scored from 1 to 5, with "1" indicating better control and resolution of symptoms, and "5" indicating increased intensity, severity and worsening. Disability is assessed in Leisure/Social, housework/errands, and work/school with scores ranging from N/A, and 1-5, with "1" indicating that itch never affects the activity, and "5" meaning that itch always affects this activity. The scores of each of the 5 domains are achieved separately and then summed together to obtain a total score. Scores can range between 5 no pruritus, and 25 most severe pruritus.
Measured: Baseline (week 0) and 12 weeks
Quality of Life as Assessed by the Dermatology Quality of Life Index From Baseline and Week 12
Quality of life as assessed by the Dermatology Quality of Life Index (DLQI). The DLQI is 10 questions used to assess impact of skin disease. Scores range from 0-30, with "0" corresponding to best quality of life, and "30" corresponding to worst quality of life.
Measured: Baseline (week 0) and 12 weeks
Pruriginous Lesions as Assessed by the Prurigo Activity Score From Baseline and Week 12
Pruriginous lesions as assessed by the Prurigo Activity Score (PAS). The PAS is a 7-item questionnaire that assesses the number, distribution and activity of pruriginous lesions. The score is calculated via summation of the scoring values, added up with 123 and afterwards divided by 10. This results in a range of values from 1.3 to 21.3.
Measured: Baseline (week 0) and 12 weeks
Itch-scratching Behavior as Assessed by Patient Reported Outcomes Measurement Information System at Baseline and Week 12
Itch-scratching behavior as assessed by Patient Reported Outcomes Measurement Information System (PROMIS®) Itch Questionnaire (PIQ) T-Score: Scratching. The PIQ T-Score: Scratching, is comprised of 5 questions to assess Itch-Scratching Behavior over the past 7 days. Scores for each question range from 1-5, Score range of 5-25 with scores of "1" indicating less scratching behavior and scores of "5" indicating the greatest scratching behavior.
A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Itch, a T-score of 60 is one SD worse than average. By comparison, an Itch T-score of 40 is one SD better than average
For PROMIS, the T-scores have a mean (SD) of 50 (10) for adults in the US experiencing itch for any reason.
Measured: Baseline (week 0) and 12 weeks
Number of Nodules at Baseline and Week 12
Number of baseline prurigo nodules over time. As part of the Prurigo Activity Score, lesions are counted in a representative body region. Lesion count within the representative area at Week 0 was compared to lesion count in the representative area at Week 12.
Measured: Baseline (week 0) and 12 weeks
Prurigo Nodule Severity at Baseline and Week 12
Prurigo nodule severity using the Investigator's Global Assessment (IGA). The IGA is a physician scale assessing the number of nodules a Prurigo Nodularis (PN) patient has. Patients receive a score between 0 and 4, where "0" is clear: "No prurigo nodules. Post-inflammatory hypo/hyper pigmentation may be present". Grades of "4" are severe: "Abundant prurigo nodules. Marked nodule elevation."
Measured: Baseline (week 0) and 12 weeks
Quality of Life as Assessed by the EuroQoL 5-Dimension at Baseline and Week 12
Quality of life as assessed by EuroQoL 5-Dimension (EQ-5D). The 3 level version of the EQ-5D (EQ-5D-3L) assesses degree of debilitation in 5 major aspects of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three possible answers. These answers equate to: "No problems" or "Some/Moderate Problems" or "Severe/Extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. A unique health state is then defined by combining one level from each of the 5 dimensions. Each state is referred to in terms of a 5-digit code. A total of 243 possible health states codes is defined in this way. State 11111 indicates no problems on any of the five dimensions. The patient then rates how good or bad their health is on that day from a range from 0 the worst health you can imagine, to 100 the best health you can imagine.
Measured: Baseline (week 0) and 12 weeks
Depression as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12
Depression as assessed by The Hospital Anxiety and Depression Scale (HADS), has 7 items relating to depression. Each item scored from 0-3 with higher scores indicating higher depression. Total score range 0-21.
Measured: Baseline (week 0) and 12 weeks
Anxiety as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12
Anxiety as assessed by The Hospital Anxiety and Depression Scale (HADS), has 7 items relating to anxiety. Each item scored from 0-3 with higher scores indicating higher anxiety. Total score range 0-21.
Measured: Baseline (week 0) and 12 weeks
Sleep Disturbance as Assessed by the SD-NRS at Baseline and Week 12
Average sleep disturbance from Week 0 and Week 12 as assessed by (SD) NRS. The SD-NRS is an 11-point scale (0 -10) with higher scores indicating greater sleep disturbance.
Measured: Baseline (week 0) and 12 weeks
Itch Intensity in Patients With Underlying Atopy at Baseline and Week 12
Itch intensity as assessed by PP-NRS in Prurigo Nodularis patients with underlying atopy. The PP-NRS is a single self-report item on an 11-point scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable. Atopy defined as a binary variable where patients have 2 out of 3: underlying history of atopic dermatitis, history of seasonal allergies, or asthma.
Measured: Baseline (week 0) and 12 weeks
Itch Intensity in Patients Without Underlying Atopy at Baseline and Week 12
Itch intensity as assessed by PP-NRS in Prurigo Nodularis patients without underlying atopy. The PP-NRS is a single self-report item on an 11-point scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable. Atopy is defined as a binary variable where patients have 2 out of 3: underlying history of atopic dermatitis, history of seasonal allergies, or asthma.
Measured: Baseline (week 0) and 12 weeks
Itch Intensity in CPUO Patients With High Eosinophilia at Baseline and Week 12
Itch intensity as measured by PP-NRS in CPUO patients with high eosinophilia (greater than 500 eosinophils per micro-liter of blood). The PP-NRS is an 11-point single self-report item on a scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable.
Measured: Baseline (week 0) and 12 weeks
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12
Lesional and non-lesional skin biopsies will be compared for Type 1/2/17/22 T Helper (Th) Th1/Th2/Th17/Th22 polarization before and after treatment. PN and CPUO patients had biopsies collected at Week 0 and at Week 12. PN patients had two biopsies collected: a lesional site and a non-lesional biopsy close by for comparison. The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions.
CPUO will be compared from week 0 to week 12. PN will compare Lesional to non Lesional at Week 0. PN will compare Lesional to Non Lesional at Week 12.
GSVA will compare gene set enrichment scores as a function of gene pathway expression which range from -1 to 1. Lower scores indicate down regulation of the gene set, and higher scores indicate up regulation.
Measured: Baseline (week 0) and 12 weeks
Systemic Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12
Plasma cytokines will be analyzed for TH1/Th2/Th17/Th22 polarization before and after treatment. This outcome was posted in error. It is not appropriate to perform GSVA of plasma cytokines. It is best practice to limit GSVA to RNASeq.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start9 Sep 2021
- Primary completion11 Jul 2022
- Study completion11 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prurigo NodularisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized study with two arms conducted in parallel: an arm of 10 Prurigo Nodularis (PN) patients, and an arm of 10 Chronic pruritus of unknown origin (CPUO) patients.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Pfizer
- Responsible party
- Sponsor
- Investigators
- Shawn G Kwatra, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038982
- Sponsor's protocol ID
- IRB00262268
- Status last verified
- Jun 2023
- First submitted
- 23 Aug 2021
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwatra SG, Bordeaux ZA, Parthasarathy V, Kollhoff AL, Alajmi A, Pritchard T, Cornman HL, Kambala A, Lee KK, Manjunath J, Ma EZ, Dillen C, Kwatra MM. Efficacy and Safety of Abrocitinib in Prurigo Nodularis and Chronic Pruritus of Unknown Origin: A Nonrandomized Controlled Trial. JAMA Dermatol. 2024 Jul 1;160(7):717-724. doi: 10.1001/jamadermatol.2024.1464.
PubMed 38837144
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety, and Tolerability of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
- ClinicalTrials.gov ID
- NCT05038982
- Acronym / sponsor ID
- IRB00262268
- Conditions
- Prurigo Nodularis, Pruritus, Chronic Pruritus, Chronic Prurigo, Skin Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Duke University, Pfizer
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess the efficacy, safety, and tolerability of Abrocitinib for the treatment of Prurigo Nodularis (PN) or Chronic Pruritus of Unknown Origin (CPUO) in patients experiencing moderate to severe pruritus.
Detailed description
This is a trial to assess the efficacy of Abrocitinib as a therapeutic for Prurigo Nodularis (PN) and Chronic Pruritus of Unknown Origin (CPUO). The study will consist of a 4-week Screening period, a 12-week treatment period and then a 4-week follow up period. The arms will run in parallel and patients will take 200 mg oral Abrocitinib daily for the duration of the 12-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-randomized study with two arms conducted in parallel: an arm of 10 Prurigo Nodularis (PN) patients, and an arm of 10 Chronic pruritus of unknown origin (CPUO) patients.
| Arm | Type | Receives |
|---|---|---|
| Prurigo Nodularis | Experimental | Drug: AbrocitinibPrurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). |
| Chronic Pruritus of Unknown Origin | Experimental | Drug: AbrocitinibChronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or female participants between ages 18-80 years at time of signing informed consent
- A clinical diagnosis of prurigo nodularis, defined by the presence of at least 10 pruritic nodules on at least 2 different anatomic locations (with each arm, leg, and anterior and posterior trunk considered distinct anatomic locations)
- OR
- Subject has ongoing chronic pruritus of unknown origin, which must be present on multiple segments on the body. CPUO patients must not have known dermatologic or systemic conditions, that in the opinion of the investigator, are the cause of patient's pruritus
- Subject has moderate to severe pruritus, defined as average peak pruritus numeric rating scale - (PP-NRS) > 7 (range 0-10, higher score indicating greater degree of pruritus severity) in the 7 days prior to the Screening Visit.
Key exclusion criteria (15 listed)
- Infected with hepatitis B or hepatitis C viruses.
- Infected with Herpes Simplex or Herpes zoster.
- Positive HIV serology at screening,
- Evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- History of lymphoproliferative disease, or active primary or recurrent malignancy
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 |
|---|---|---|
| AbrocitinibDuring the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day. | Drug | Chronic Pruritus of Unknown Origin, Prurigo Nodularis |
Primary outcome
Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12
Time frame: Up to 12 weeks
Percent change in weekly average PP-NRS at Week 12. PP-NRS is a single self-report item on an 11-point scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable.
16 secondary outcomes
Number of Subjects Achieving a Reduction in Weekly Average PP-NRS From Baseline to Week 12
Time frame: Up to 12 weeks
Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Quality of Life as Assessed by the Dermatology Quality of Life Index From Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Pruriginous Lesions as Assessed by the Prurigo Activity Score From Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Itch-scratching Behavior as Assessed by Patient Reported Outcomes Measurement Information System at Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Number of Nodules at Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Prurigo Nodule Severity at Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Quality of Life as Assessed by the EuroQoL 5-Dimension at Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Depression as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Anxiety as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Sleep Disturbance as Assessed by the SD-NRS at Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Itch Intensity in Patients With Underlying Atopy at Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Itch Intensity in Patients Without Underlying Atopy at Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Itch Intensity in CPUO Patients With High Eosinophilia at Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12
Time frame: Baseline (week 0) and 12 weeks
Systemic Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38837144Kwatra SG, Bordeaux ZA, Parthasarathy V, Kollhoff AL, Alajmi A, Pritchard T, Cornman HL, Kambala A, Lee KK, Manjunath J, Ma EZ, Dillen C, Kwatra MM. Efficacy and Safety of Abrocitinib in Prurigo Nodularis and Chronic Pruritus of Unknown Origin: A Nonrandomized Controlled Trial. JAMA Dermatol. 2024 Jul 1;160(7):717-724. doi: 10.1001/jamadermatol.2024.1464.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Shawn G Kwatra, MD principal investigator
Johns Hopkins University
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 Abrocitinib in people with Prurigo Nodularis and Pruritus, run by Johns Hopkins University 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 6 inclusion and 15 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: finished, as of the sponsor's last update on 3 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12 (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05038982, which also lists 1 linked publication.
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 Jul 2023.