Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis

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

1. whether tofacitinib is effective in treating prurigo nodularis in the longpterm.
2. whether tofacitinib is safe in prurigo nodularis patients in the longpterm.

Study Overview

• Status: Not yet recruiting
• Conditions: Prurigo Nodularis; Itch
• Intervention / Treatment: Drug: Tofacitinib 5 MG

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ru Dai; Phone Number: +8615982215914; Email: dairu@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Ru Dai, Ph.D; Phone Number: 86 15982215914; Email: dairu@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tofacitinib	Drug: Tofacitinib 5 MG; 5mg tofacitinib tablet twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator's global assessment	a 11-point scale ranging from -5 (obvious aggravation) to 5(marked improvement) points.	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.	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.	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.	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.	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.	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.	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Prurigo; Neurodermatitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Janus Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: 20231186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No