Phase 2
N=382
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
Chronic Spontaneous Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT02477332 ↗Enrolled (actual)
382
Serious AEs
4.7%
Results posted
Sep 2018
Primary outcome: Primary: Percentage of Participants With Complete Hives Response (HSS7=0) — 30.2; 51.2; 42.4; 25.9 Percentage of participants — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- QGE031 (Biological); Omalizumab (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Hives Response (HSS7=0) |
30.2; 51.2; 42.4; 25.9; 0; 19.0 | <.05 sig |
| SECONDARY Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days |
13; 43; 36; 22; 0 | — |
| SECONDARY Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days |
-9.75; -15.50; -13.50; -11.00; -6.50 | — |
| SECONDARY HSS7=0 Response: at Week 20 Measured Over 7 Days |
11; 43; 38; 29; 4 | — |
| SECONDARY Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days |
-9.00; -16.50; -14.00; -11.00; -7.50 | — |
| SECONDARY Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days |
-7.50; -9.50; -9.00; -8.00; -5.50 | — |
| SECONDARY Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days |
-7.00; -10.25; -10.00; -8.83; -5.00 | — |
| SECONDARY Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days |
-19.50; -26.50; -21.75; -19.00; -12.00 | — |
| SECONDARY Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days |
-16.00; -27.00; -22.92; -18.50; -13.00 | — |
| SECONDARY Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days |
13; 37; 34; 22; 0 | — |
| SECONDARY UAS7=0 Response: at Week 20 Measured Over 7 Days |
8; 33; 34; 26; 2 | — |
| SECONDARY Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days |
17; 40; 36; 25; 2 | — |
| SECONDARY ISS7=0 Response: at Week 20 Measured Over 7 Days |
8; 35; 36; 28; 3 | — |
Summary
This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02477332). 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.