Phase 2 N=226 Treatment

A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

Chronic Spontaneous Urticaria

Bottom Line

View on ClinicalTrials.gov: NCT02649218 ↗

Enrolled (actual)

226

Serious AEs

4.7%

Results posted

Aug 2020

Primary outcome: Primary: Number of Participants With at Least One Treatment Emergent Adverse Event (AE) — 190 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ligelizumab (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With at Least One Treatment Emergent Adverse Event (AE)	190	—
SECONDARY Percentage of Subjects Having Achieved UAS7 ≤ 6	0.44; 61.06; 28.32	—
SECONDARY Number and Proportion of Participants Who Achieved UAS7≤ 6	1; 138; 64	—

Summary

A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201

Eligibility Criteria

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
Written informed consent must be obtained before any assessment is performed.
Patients who complete the treatment epoch in study CQGE031C2201 and complete at least Visit 203 (Week 32 of the follow-up epoch, ≥16 weeks after last injection) and present with active disease as defined by UAS7 ≥12.
Patients must not have any missing eDiary entries in the 7 days prior to Visit 301 (patients are allowed to repeat until this criterion is met).
Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.

Exclusion Criteria

Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria

Evidence of parasitic infection
Any other skin diseases than chronic spontaneous urticaria with chronic itching
Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine
History of anaphylaxis
History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
History of hypersensitivity to any of the study drugs or its components of similar chemical classes
Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02649218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.