A new phase 2 clinical trial comparing the safety and efficacy of baricitinib plus danazol to those of danazol alone in patients with immune thrombocytopenia (ITP) is now open.
The prospective, multicenter, randomized controlled trial sponsored by Peking University People’s Hospital will recruit 216 participants aged 18 to 70 years with primary ITP who are steroid resistant or have relapsed following steroid treatment at multiple locations in China.
Read more about ITP types
Participants will be randomly assigned to receive either 2 mg of baricitinib once a day plus 200 mg of danazol twice a day or only 200 mg of danazol twice a day for 6 months.
The primary outcome measures will be the maintenance of a platelet count of 30,000/μL or more, at least a 2-fold increase in the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up.
Secondary outcome measures include a platelet count over 100,000/μL and the absence of bleeding (a complete response), the time from the start of treatment to achieving a response, the number of bleeding events, health-related quality of life, and adverse events.
People with secondary ITP, those who have a history of malignancy or myocardial infarction, and those who are pregnant or breastfeeding are not eligible to take part in the study. The full eligibility criteria can be found on the clinical trial website.
The study opened on May 10, 2023 but is not yet recruiting participants. The estimated completion date is May 2025.
ITP is a rare bleeding disorder characterized by a platelet count below 100,000/µL. The disease can be classified as primary or secondary. Primary ITP is an acquired autoimmune disorder, while secondary ITP is associated with underlying disorders, chronic infections, or drugs.
Danazol is a synthetic steroid that can be used to treat patients with ITP, but its efficacy is uncertain.
Baricitinib is an immunomodulatory drug that inhibits Janus kinase (JAK) 1 and JAK2. It is used to treat rheumatoid arthritis, among other diseases.
Reference
Low-dose baricitinib plus danazol for steroid-resistant/relapse immune thrombocytopenia. ClinicalTrials.gov. May 10, 2023. Accessed May 17, 2023.
