Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis

Itch Clinical Trial

Official title:

Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis: a Prospective, Observational Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06201715
• Other study ID #: 20231186
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: September 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Ru Dai
• Phone: +8615982215914
• Email: dairu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. age =18 years old;

2. patients diagnosed with PN with a duration of more than 6 months;

3. presence of at least 10 pruritic nodules;

4. a Worst Itch-Numeric Rating Scale (WI-NRS) score =7 one week before study;

5. a history of more than 2 weeks of ineffective topical glucocorticoid treatment or antihistamine therapy;

6. signed informed consent and cooperated with the follow up and complied the study protocol.

Exclusion criteria:

1. current used of biologic, systemic glucocorticoid or immunosuppressive agents; past used of jak inhibitors;

2. were pregnant or lactating;

3. abnormal findings for patients' complete blood count, liver functions, and kidney function tests;

4. presence of any infection or inflammatory; presence of active tumors or an increased risk of tumor complications;

5. systemic comorbidities that could interfere with or complicate study assessments.

6. those experiencing atopic dermatitis within 6 months were excluded from this study.

Related Conditions & MeSH terms

• Itch
• Neurodermatitis
• Prurigo
• Prurigo Nodularis

Intervention

Drug:
• Tofacitinib 5 MG
5mg tofacitinib tablet twice daily

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's global assessment	a 11-point scale ranging from -5 (obvious aggravation) to 5(marked improvement) points.	up to 12 weeks
Primary	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.	up to 12 weeks
Primary	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.	up to 12 weeks
Primary	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.	up to 12 weeks
Primary	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.	up to 12 weeks
Primary	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.	up to 12 weeks
Primary	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.	up to 12 weeks
Secondary	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	up to 16 weeks