Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/6/2018 |
| Start Date: | July 15, 2015 |
| End Date: | June 12, 2017 |
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)
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.
safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic
Spontaneous Urticaria.
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.
We found this trial at
26
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials