Conditions: Asthma
Keywords: asthma asthma control allergy atopic IgE double-blind placebo omalizumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 471
Healthy volunteers: no

Brief summary:
This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.

Detailed description:

Arms:
arm 1: Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks. arm 2: Participants received QGE031 240 mg s.c. q4w for 16 weeks. arm 3: Participants received QGE031 180 mg s.c. q2w for 16 weeks. arm 4: Participants received QGE031 120 mg s.c. q2w for 16 weeks. arm 5: Participants received QGE031 36 mg s.c. q2w for 16 weeks. arm 6: Participants received QGE031 12 mg s.c. q2w for 16 weeks. arm 7: Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks. arm 8: Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks. arm 9: Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks. arm 10: Participants received QGE031 180 mg s.c. q2w for 16 weeks. arm 11: Participants received QGE031 120 mg s.c. q2w for 16 weeks. arm 12: Participants received QGE031 36 mg s.c. q2w for 16 weeks. arm 13: Participants received QGE031 12 mg s.c. q2w for 16 weeks. arm 14: Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.

Interventions: intervention 1: QGE031 intervention 2: Omalizumab intervention 3: Placebo
Intervention descriptions: intervention 1: QGE031 was supplied as 120 mg liquid in vial per 1 mL intervention 2: Omalizumab was supplied as 150 mg lyophilisate in vial intervention 3: Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL

Protocol document: