Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Novartis Pharmaceuticals
The study consisted of a 28-day screening period, a blinded treatment period of 28 weeks where randomized patients received treatment with investigational drug (ianalumab or iscalimab) or placebo. At the end of Week 29 visit, the patients entered the open-label treatment phase where patients in active treatment group continued to receive active treatment and patients in placebo group started active treatment with ianalumab/iscalimab until Week 49. After completion of the open-label treatment period, all patients entered a Follow-Up period in order to monitor safety and efficacy up to Week 69. The Week 69 visit was the End of Study (EoS) visit for patients in Cohort 2 (CFZ533). Study duration for patients in Cohort 2 was approximately 18 months. For Cohort 1 (VAY736), patients who did not achieve B-cell recovery by Week 69 Visit entered into a Secondary Follow-Up period until achieving B cell recovery criteria (B-cell count was at \>= 50 cells/µl or at least 80% of baseline levels). Safety follow-up visits were scheduled as deemed appropriate until the patient achieved the B-cell recovery criteria, followed by an EoS 4 weeks later.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
