AJOVY was evaluated in three phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group trials, and a Long-Term Extension study1-6
HALO trial designs
1000+ patients received AJOVY as a stand-alone preventive treatment1
280+ patients continued to receive their oral preventive treatment1
Nearly 600 patients had discontinued prior preventive treatment2
18% of women of childbearing age also took concomitant hormonal contraceptives2
There are no adequate data on the developmental risk associated with the use of AJOVY in pregnant women. This should be taken into consideration for women who are pregnant or plan to become pregnant while using AJOVY.1
HALO TRIAL DESIGNS3,4
CHRONIC MIGRAINE (CM) & EPISODIC MIGRAINE (EM)
AJOVY monthly treatment arm
CM: 675 mg dose at week 0 (three injections of 225 mg per 1.5 mL) and 225 mg at weeks 4 and 8 (one injection of 225 mg per 1.5 mL at each visit)
EM: 225 mg dose at week 0 (one injection of 225 mg per 1.5 mL and two 1.5 mL injections of placebo), and 225 mg at week 4 and 8 (one injection of 225 mg per 1.5 mL at each visit)
AJOVY quarterly treatment arm
Single dose of 675 mg at week 0 (three injections of 225 mg per 1.5 mL), followed at weeks 4 and
8 by placebo (one 1.5 mL injection at each visit)
Placebo treatment arm
Three 1.5 mL injections at week 0 and 1.5 mL injection at weeks 4 and 8
CM: defined as ≥15 headache days per month3; EM: defined as <15 headache days per month.4
LONG-TERM EXTENSION STUDY5
AJOVY was evaluated in a 12-month, multicenter, randomized, double-blind, parallel-group study evaluating monthly or quarterly dosing.
- As the primary purpose of the study was the collection of long-term safety data for patients treated with AJOVY, the study was not placebo controlled. Patients and investigators were both blinded to the dosing regimen (monthly vs quarterly) to allow for comparisons between the two dosing options
- The study included 1890 patients with CM (1110) and EM (780)
LONG-TERM EXTENSION STUDY5
CHRONIC MIGRAINE (CM) & EPISODIC MIGRAINE (EM)
AJOVY monthly treatment arm
CM (HALO placebo & new patients): 675 mg dose at month 0 (three injections of 225 mg per 1.5 mL), followed by 225 mg at months 1–12
CM (HALO patients): 225 mg dose at months 0–12 (one injection of 225 mg per 1.5 mL and two 1.5 mL injections of placebo)
EM (HALO & new patients): 225 mg dose at months 0–12 (one injection of 225 mg per 1.5 mL and two 1.5 mL injections of placebo)
AJOVY quarterly treatment arm
Single dose of 675 mg at month 0 (three injections of 225 mg per 1.5 mL), followed by month 3, 6, 9, and 12, and placebo (one 1.5 mL injection) at months 1, 2, 4, 5, 7, 8, 10, and 11
CM: defined as ≥15 headache days per month3; EM: defined as <15 headache days per month.4
FOCUS TRIAL DESIGN6
AJOVY was evaluated in a phase 3b, multicenter, randomized, double-blind, parallel-group, placebo-controlled study evaluating efficacy and safety of quarterly and monthly treatment with AJOVY, compared to placebo in patients with chronic or episodic migraine who had experienced an inadequate response* to 2–4 classes of prior preventive treatments.
- The study randomized 838 patients with chronic and episodic migraine
- Inadequate response to a prior medication was defined as: (1) no clinically meaningful improvement after at least 3 months (2) patient could not tolerate the drug (3) drug was contraindicated for patient or (4) drug was not suitable for the patient.
FOCUS TRIAL DESIGN6
CHRONIC MIGRAINE (CM) & EPISODIC MIGRAINE (EM)
AJOVY monthly treatment arm
CM: 675 mg dose at week 0 (three injections of 225 mg per 1.5 mL) and 225 mg at weeks 4 and 8 (one injection of 225 mg per 1.5 mL at each visit)
EM: 225 mg dose at week 0 (one injection of 225 mg per 1.5 mL and two 1.5 mL injections of placebo), and 225 mg at weeks 4 and 8 (one injection of 225 mg per 1.5 mL at each visit)
AJOVY quarterly treatment arm
Single dose of 675 mg at week 0 (three injections of 225 mg per 1.5 mL), followed at weeks 4 and
8 by placebo (one 1.5 mL injection at each visit)
Placebo treatment arm
Three 1.5 mL injections at week 0 and 1.5 mL injection at weeks 4 and 8
CM: defined as ≥15 headache days per month2; EM: defined as <15 headache days per month.4
See efficacy results for AJOVY
