Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Jan 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called tofacitinib to see how well it works and how safe it is for patients with prurigo nodularis, a condition that causes severe itching and bumps on the skin. The study aims to find out if tofacitinib can help reduce the itching and improve the skin condition over a longer period of time. It is important for patients who have not had success with other treatments to consider participating in this trial.

To be eligible, participants need to be at least 18 years old and have been diagnosed with prurigo nodularis for over six months. They should have at least 10 itchy nodules and a high score on a scale that measures itchiness. Additionally, they should have tried topical treatments or antihistamines that didn’t work for them. However, individuals currently taking certain medications, pregnant or breastfeeding women, or those with some health issues will not be eligible to join. If you participate, you will receive the medication and be monitored closely to see how it affects your condition and any side effects you may experience.

Gender

ALL

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.