QGE031 Phase 2b dose-finding study to investigate efficacy and safety in adolescents with CS

Phase 1

• Conditions: Chronic Spontaneous Urticaria; MedDRA version: 20.0Level: PTClassification code 10072757Term: Chronic spontaneous urticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-004207-52-EE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-01
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

- Parent or legal guardian’s written informed consent and child’s assent
- Male and female adolescent patients aged = 12 to <18 years at the time of screening
- CSU diagnosis = 6 months and presence of itch and hives for at least 6 consecutive weeks at any time prior to enrollment
- Diagnosis of CSU refractory to approved doses of H1-antihistamines at the time of randomization
- Other protocol-defined criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 48
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Clearly defined underlying etiology for chronic urticarias other than CSU
- Any other skin disease associated with chronic itching that might confound the study evaluations and results
- Previous exposure to omalizumab
- History of anaphylaxis
- Other protocol-defined criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the change in the Urticaria Activity Score (UAS7) between baseline and Week 24;Primary end point(s): Change in the Urticaria Activity Score (UAS7) between baseline and Week 24;Timepoint(s) of evaluation of this end point: 24 weeks;Secondary Objective: - To evaluate the efficacy of ligelizumab doses with respect to UAS7 change from baseline <br>- To evaluate the efficacy of ligelizumab doses on complete response in Urticaria Activity Score (UAS7=0), Hives Severity Score (HSS=0), Itch Severity score (ISS=0)<br>- To investigate the effects on ISS7 and HSS7 when compared to baseline<br>- To investigate the pharmacokinetics and Pharmacodynamics of ligelizumab<br>- Change from baseline in the Children Dermatology Life Quality Index <br>- To evaluate the safety (including immunogenicity) and tolerability of ligelizumab versus placebo in patients with CS

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: - At each protocol defined study visit;Secondary end point(s): - UAS7 change from baseline over time <br>- Rate of complete responders (UAS7=0, HSS7=0, ISS7 =0) over time<br>- Itch severity score and Hives severity score change from baseline over time<br>- Model-based estimate of clearance and volume of distribution using at least 7 samples<br>- Summary statistics of change in Total IgE over time<br>- Children Dermatology Life Quality Index change from baseline over time<br>- Adverse events, ECG-intervals and interpretation, vital signs (blood pressure, pulse rate) and clinical laboratory evaluation