A Phase 1, Open-label, Multiple Ascending Dose Basket Study to Evaluate the Safety and Activity of DR-0201 in Patients with Select Autoimmune Rheumatic Diseases (NCT06647069)

The DR-0201-AIM-001 study is designed to evaluate the safety and efficacy of DR-0201 in adult participants with lupus, primary Sjögren’s syndrome and/or scleroderma.
Participants receive trial medication via an infusion over 26 weeks at varying intervals.
 

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Professor Johannes S Kern

Key inclusion data

Aged between 18-75 years of age at screening
Have a diagnosis of SLE/CLE, primary Sjögren’s syndrome and/or scleroderma for less than 3 years
Be willing to undergo skin biopsies at screening and during treatment period