Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis

NCT ID: NCT06201715

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-12-30

Brief 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.

Conditions

Prurigo Nodularis; Itch

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tofacitinib

Group Type: EXPERIMENTAL

Tofacitinib 5 MG

Intervention Type: DRUG

5mg tofacitinib tablet twice daily

Interventions

Tofacitinib 5 MG

5mg tofacitinib tablet twice daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Second Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Ru Dai

Role: CONTACT

dairu@zju.edu.cn

+8615982215914

Facility Contacts

Ru Dai, Ph.D

Role: primary

dairu@zju.edu.cn

86 15982215914

Other Identifiers

20231186

Identifier Type: -

Identifier Source: org_study_id