Clinical trial NCT03570749: A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
Conditions: Alopecia Areata
Summary: This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.
Interventions:
description: Administered orally.
name: Baricitinib
other_name: LY3009104
type: Drug
description: Administered orally.
name: Placebo
type: Drug
Study arms:
design_group_description: Participants received three placebo tablets administered orally once daily (QD). Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve Severity of Alopecia Tool (SALT) ≤20 (less than or equal to 20) during the study period.
design_group_title: Placebo Phase 2
design_group_type: Placebo Comparator
design_group_description: Participants received one 1 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind through Week 12. Following the decision point at Week 12, participants were transitioned to receive one 4 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind, and continued treatment through Week 200.
design_group_title: 1 Milligram (mg) / 4 mg Baricitinib Phase 2
design_group_type: Experimental
design_group_description: Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
design_group_title: 2 mg Baricitinib Phase 2
design_group_type: Experimental
design_group_description: Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.
design_group_title: 4 mg Baricitinib Phase 2
design_group_type: Experimental
design_group_description: Participants received two placebo tablets administered orally QD. Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve SALT≤20 during this treatment period.
design_group_title: Placebo Phase 3
design_group_type: Placebo Comparator
design_group_description: Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
design_group_title: 2 mg Baricitinib Phase 3
design_group_type: Experimental
design_group_description: Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
design_group_title: 4 mg Baricitinib Phase 3
design_group_type: Experimental
design_group_description: Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.
design_group_title: Placebo/ Placebo Phase 3
design_group_type: Placebo Comparator
design_group_description: Participants who received Placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.
design_group_title: Placebo/ 2 mg Baricitinib Phase 3
design_group_type: Experimental
design_group_description: Participants who received Placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
design_group_title: Placebo/ 4 mg Baricitinib Phase 3
design_group_type: Experimental
design_group_description: Participants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.
design_group_title: 2 mg Baricitinib /2 mg Baricitinib Phase 3
design_group_type: Experimental
design_group_description: Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
design_group_title: 2 mg Baricitinib /4 mg Baricitinib Phase 3
design_group_type: Experimental
design_group_description: Participants who received 2 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
design_group_title: 2 mg Baricitinib / Placebo Phase 3
design_group_type: Experimental
design_group_description: Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
design_group_title: 4 mg Baricitinib / Placebo Phase 3
design_group_type: Experimental
design_group_description: Participants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2.
design_group_title: 4 mg Baricitinib /4 mg Baricitinib Phase 3
design_group_type: Experimental
design_group_description: Participants who received one 4 mg Baricitinib tablet administered orally QD.
design_group_title: 4 mg Baricitinib Phase 3 Open-Label Addendum
design_group_type: Experimental
Sponsor: Eli Lilly & Co.
Collaborators: Incyte Corp.
Drug name mappings:
name: 巴瑞替尼
lang: CN
name: Baricitinib
lang: EN