study of efficacy and safety of ligelizumab in chronic spontaneous urticaria patients who completed a previous study with ligelizumab

Conditions: Chronic Spontaneous Urticaria

Summary: the purpose of this extension study was to establish efficacy and safety of ligelizumab. this was assessed in adult and adolescent chronic spontaneous urticaria (csu) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care h1-antihistamine (h1-ah) treatment. this study also fulfilled the novartis commitment to provide post-trial access to patients who had completed studies: cqge031c2302 (nct03580369), cqge031c2303 (nct03580356), cqge031c2202 (nct03437278) or cqge031c1301 (nct03907878).

this was a phase iiib multi-center, double-blinded and open-label extension study to evaluate efficacy and safety of ligelizumab retreatment with h1-ahs background therapy with an option for ligelizumab monotherapy (i.e., discontinuation of background h1-ah) in adult and adolescent csu participants who had completed one of the preceding studies, in the setting of retreatment and self-administration. participants with weekly urticaria activity score (uas7) \< 16 during screening entered the first (investigational treatment-free) observation period (obs1), with a duration up to 36 weeks. participants with uas7 ≥ 16 during screening or obs1 were assigned to 1 of the 2 treatment arms and entered the treatment period (first half treatment period, referred to as trt1). the first half treatment period (trt1) was 52 weeks (from week 0 to week 52). participants remained on the same h1-ah background medication they were taking in the preceding studies. trt1 was divided into: * the first 12 weeks in trt1: i. participants transitioning from cqge031c2302 (nct03580369) and cqge031c2303 (nct03580356) previously treated with ligelizumab 72 mg liquid in vial subcutaneously (s.c.) every 4 weeks (q4w) were treated with the same dose regimen in a double-blind manner in this extension study; ii. all other participants transitioning from cqge031c2302 (nct03580369) and cqge031c2303 (nct03580356) were treated with ligelizumab 120 mg liquid in vial s.c., q4w, in a double-blind manner in this extension study; iii. participants transitioning from cqge031c1301 (nct03907878) and cqge031c2202 (nct03437278) were treated with ligelizumab 120 mg liquid in vial s.c., q4w in an open-label manner in this extension study. * after the first 12 weeks in trt1 (and up to week 52), all participants were switched to ligelizumab 120 mg s.c. pre-filled syringe (pfs) q4w in an open-label manner and they were offered an opportunity to self-administer ligelizumab outside the clinic. the second half of the treatment period (trt2) was 52 weeks (from week 52 to week 104). participants with uas7\>6 and \<16 or with uas7 ≥ 16 for whom the benefit-risk was deemed as positive by the investigator at week 52 of trt1 were transitioned to the trt2 (ligelizumab 120 mg s.c. q4w pfs) unless a decision to stop treatment was made based on a risk-benefit assessment. they were not allowed to discontinue h1- ah background medication. participants with uas7 ≤ 6 at week 52 of trt1 entered the second (investigational treatment-free) observation period (obs2) for up to 52 weeks and remained on the same h1-ah background medication they were taking in the preceding studies. participants with uas7 ≤ 6 at week 52 of trt1 who entered the second observation period (obs2) and relapsed (uas7 ≥ 16) were transitioned to the trt2 and were also offered the opportunity to discontinue their h1-ah background medication (i.e. ligelizumab 120 mg s.c. q4w pfs monotherapy) after 12 weeks in trt2. participants who entered the obs2 and did not relapse (uas7\<16) exited the study at the end of the obs2 period. finally, participants who were in trt2 entered the post-treatment follow-up period after treatment discontinuation, with duration of 12 weeks (for participants who did not complete a continuous 104-week treatment) or 52 weeks (for participants who completed the full 104-week treatment period without interruption). participants who decided to remain on h1-ah background medication continued to use h1-ah background medication. participants who decided to go off h1- ah background medication continued to remain off.

Eligibility criteria:
key inclusion criteria: * written informed consent * subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: cqge031c2302 (nct03580369), cqge031c2303 (nct03580356), cqge031c2202 (nct03437278) or cqge031c1301 (nct03907878) * male and female, adult and adolescent subjects ≥12 years of age * willing and able to complete a daily symptom ediary for the duration of the study and adhere to the study visit schedule key exclusion criteria: * use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment * use of omalizumab within 16 weeks of screening * history of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes * new onset or signs and symptoms of any form of chronic urticarias other than csu during the preceding studies cqge031c2302 (nct03580369), cqge031c2303 (nct03580356) or cqge031c2202 (nct03437278). * diseases with possible symptoms of urticaria or angioedema * subjects with evidence of helminthic parasitic infection * documented history of anaphylaxis * pregnant or nursing (lactating) women

Keywords: anti-ige chronic spontaneous urticaria hives severity score itch severity score urticaria activity score csu