Prurigo NodularisNCT06201715
Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis
A study testing Tofacitinib 5 MG in people with Prurigo Nodularis and Itch, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal is to evaluate the efficacy and safety of tofacitinib in treating refractory prurigo nodularis.The main questions it aims to answer are 1. whether tofacitinib is effective in treating prurigo nodularis in the longpterm. 2. whether tofacitinib is safe in prurigo nodularis patients in the longpterm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prurigo Nodularis, Itch
- What is being tested?
- Tofacitinib 5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Dec 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years old;
- patients diagnosed with PN with a duration of more than 6 months;
- presence of at least 10 pruritic nodules;
- a Worst Itch-Numeric Rating Scale (WI-NRS) score ≥7 one week before study;
- a history of more than 2 weeks of ineffective topical glucocorticoid treatment or antihistamine therapy;
- signed informed consent and cooperated with the follow up and complied the study protocol.
Who cannot join
- current used of biologic, systemic glucocorticoid or immunosuppressive agents; past used of jak inhibitors;
- were pregnant or lactating;
- abnormal findings for patients' complete blood count, liver functions, and kidney function tests;
- presence of any infection or inflammatory; presence of active tumors or an increased risk of tumor complications；
- systemic comorbidities that could interfere with or complicate study assessments.
- those experiencing atopic dermatitis within 6 months were excluded from this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
Ru Dai, Ph.D, 86 15982215914, dairu@zju.edu.cn
About this study
Official title: Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis: a Prospective, Observational Pilot Study
The goal is to evaluate the efficacy and safety of tofacitinib in treating refractory prurigo nodularis.The main questions it aims to answer are
- whether tofacitinib is effective in treating prurigo nodularis in the longpterm.
- whether tofacitinib is safe in prurigo nodularis patients in the longpterm.
- Conditions
- Prurigo Nodularis, Itch
- Being tested
- Tofacitinib 5 MG
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib 5 MGDrug
5mg tofacitinib tablet twice daily
| Study group | Role | What they receive |
|---|---|---|
| tofacitinib | Experimental | Not described Receives: Drug: Tofacitinib 5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's global assessment
a 11-point scale ranging from -5 (obvious aggravation) to 5(marked improvement) points.
Measured: up to 12 weeks
Prurigo Activity Score
The PAS is a 7-item questionnaire evaluating the type, distribution and size of pruriginous lesions, the representative body area and exact number of lesions, the activity in the terms of percentage of pruriginous lesions with excoriations/crusts on top and the percentage of healed pruriginous lesions, which is proved to be a useful tool to objectively measure PN patients over time.
Measured: up to 12 weeks
Visual analogue scale (VAS) at week 12
The VAS is a visual scale for itch on a horizontal 10-cm line, on which the left end is marked as "no itch" and the right end is marked "worst imaginable itch". We defined the average pruritus of the past 24 hours as VAS24h, average, and the worst and average pruritus of the past 4 weeks as VAS4w, worst and VAS4w, average.
Measured: up to 12 weeks
Numeric rating scale at week 12
The NRS is a similar tool for the measurement of itch ranging from 0 (no itch) to 10 (unbearable itch). Similarly, we defined the average and worst pruritus of the past 24 hours using NRS as NRS24h, average and NRS24h, worst.
Measured: up to 12 weeks
Verbal rating scale (VRS) at week 12
The VRS is a 5-point questionnaire that indicated different itching intensities as follows: 0=none; 1=mild; 2=moderate; 3=severe; 4= very severe. The VRS24h, average, VRS24h, worst and VRSevening represented 24-hour average, worst as well as average evening pruritus by VRS.
Measured: up to 12 weeks
Dermatology Life Quality Index (DLQI) at week 12
The DLQI is a questionnaire with scores ranging from 0 to 30. The total scores of 30 points represent the worst possible quality of life due to pruritus and a change of the score of ≥4 points is considered to be clinically important.
Measured: up to 12 weeks
Itchy specific quality of life (Itchy QoL) at week 12
The Itchy QoL includes 22 pruritus-specific items as follows: 6 symptoms, 7 functional limitation, and 9 emotions.
Measured: up to 12 weeks
Secondary outcomes (1)
the proportion of patients with reduction in WI-NRS by ≥4 points from baseline at week 12 and week 16.
WI-NRS represents Worst Itch-Numeric Rating Scale score
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Tofacitinib, an oral pan-JAK inhibitor, mainly selective against JAK1 and JAK3.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201715
- Sponsor's protocol ID
- 20231186
- Status last verified
- Sep 2023
- First submitted
- 2 Jan 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are not publicly available due to the privacy of research participants but are available from the sponsor upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis: a Prospective, Observational Pilot Study
- ClinicalTrials.gov ID
- NCT06201715
- Acronym / sponsor ID
- 20231186
- Conditions
- Prurigo Nodularis, Itch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 11 Jan 2024 (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 goal is to evaluate the efficacy and safety of tofacitinib in treating refractory prurigo nodularis.The main questions it aims to answer are
- whether tofacitinib is effective in treating prurigo nodularis in the longpterm.
- whether tofacitinib is safe in prurigo nodularis patients in the longpterm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Tofacitinib, an oral pan-JAK inhibitor, mainly selective against JAK1 and JAK3.
| Arm | Type | Receives |
|---|---|---|
| tofacitinib | Experimental | Drug: Tofacitinib 5 MG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥18 years old;
- patients diagnosed with PN with a duration of more than 6 months;
- presence of at least 10 pruritic nodules;
- a Worst Itch-Numeric Rating Scale (WI-NRS) score ≥7 one week before study;
- a history of more than 2 weeks of ineffective topical glucocorticoid treatment or antihistamine therapy;
Key exclusion criteria (6 listed)
- current used of biologic, systemic glucocorticoid or immunosuppressive agents; past used of jak inhibitors;
- were pregnant or lactating;
- abnormal findings for patients' complete blood count, liver functions, and kidney function tests;
- presence of any infection or inflammatory; presence of active tumors or an increased risk of tumor complications；
- systemic comorbidities that could interfere with or complicate study assessments.
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 |
|---|---|---|
| Tofacitinib 5 MG5mg tofacitinib tablet twice daily | Drug | tofacitinib |
Primary outcome
Investigator's global assessment
Time frame: up to 12 weeks
a 11-point scale ranging from -5 (obvious aggravation) to 5(marked improvement) points.
Prurigo Activity Score
Time frame: up to 12 weeks
The PAS is a 7-item questionnaire evaluating the type, distribution and size of pruriginous lesions, the representative body area and exact number of lesions, the activity in the terms of percentage of pruriginous lesions with excoriations/crusts on top and the percentage of healed pruriginous lesions, which is proved to be a useful tool to objectively measure PN patients over time.
Visual analogue scale (VAS) at week 12
Time frame: up to 12 weeks
The VAS is a visual scale for itch on a horizontal 10-cm line, on which the left end is marked as "no itch" and the right end is marked "worst imaginable itch". We defined the average pruritus of the past 24 hours as VAS24h, average, and the worst and average pruritus of the past 4 weeks as VAS4w, worst and VAS4w, average.
Numeric rating scale at week 12
Time frame: up to 12 weeks
The NRS is a similar tool for the measurement of itch ranging from 0 (no itch) to 10 (unbearable itch). Similarly, we defined the average and worst pruritus of the past 24 hours using NRS as NRS24h, average and NRS24h, worst.
Verbal rating scale (VRS) at week 12
Time frame: up to 12 weeks
The VRS is a 5-point questionnaire that indicated different itching intensities as follows: 0=none; 1=mild; 2=moderate; 3=severe; 4= very severe. The VRS24h, average, VRS24h, worst and VRSevening represented 24-hour average, worst as well as average evening pruritus by VRS.
Dermatology Life Quality Index (DLQI) at week 12
Time frame: up to 12 weeks
The DLQI is a questionnaire with scores ranging from 0 to 30. The total scores of 30 points represent the worst possible quality of life due to pruritus and a change of the score of ≥4 points is considered to be clinically important.
Itchy specific quality of life (Itchy QoL) at week 12
Time frame: up to 12 weeks
The Itchy QoL includes 22 pruritus-specific items as follows: 6 symptoms, 7 functional limitation, and 9 emotions.
1 secondary outcome
the proportion of patients with reduction in WI-NRS by ≥4 points from baseline at week 12 and week 16.
Time frame: up to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: No. The data that support the findings of this study are not publicly available due to the privacy of research participants but are available from the sponsor upon reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tofacitinib 5 MG in people with Prurigo Nodularis and Itch, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 1 Apr 2024. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru Dai (+8615982215914, dairu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator's global assessment (time frame: up to 12 weeks). The study lists 7 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 1 Apr 2024.