Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02477332
• Date of registration: 11/06/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
• Scientific title: A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)
• Date of first enrolment: July 15, 2015
• Target sample size: 382
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02477332
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, Germany, Greece, Japan, Russian Federation, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of chronic spontaneous urticaria for at least 6 months

- Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of
randomization

Exclusion Criteria:

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

- Evidence of parasitic infection

- Any other skin disease with chronic itching

- Previous treatment with omalizumab or QGE031

- 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Spontaneous Urticaria

Intervention(s)

Biological: QGE031

Other: Placebo

Biological: Omalizumab

Primary Outcome(s)

Percentage of Participants With Complete Hives Response (HSS7=0) [Time Frame: Week 12]

Secondary Outcome(s)

Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days [Time Frame: Week 12]

Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days [Time Frame: Week 20]

Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days [Time Frame: Week 20]

HSS7=0 Response: at Week 20 Measured Over 7 Days [Time Frame: Week 20]

UAS7=0 Response: at Week 20 Measured Over 7 Days [Time Frame: Week 20]

Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days [Time Frame: Week 12]

Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days [Time Frame: Week 12]

Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days [Time Frame: Week 20]

ISS7=0 Response: at Week 20 Measured Over 7 Days [Time Frame: Week 20]

Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days [Time Frame: Week 12]

Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days [Time Frame: Week 12]

Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days [Time Frame: Week 12]

Secondary ID(s)

2014-005559-16

CQGE031C2201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/09/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02477332