A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age.
The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension (LTE) Period, and a 4-week Post-treatment Follow-up period. Some individuals may be eligible to receive treatment after completing the LTE, for a maximum of 180 weeks.
Inclusion Criteria:
Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old).
Have severe areata alopecia (AA) for at least 1 year
Diagnosis for at least 1 year
Current AA episode of at least 6 months' duration
SALT score ≥50% at screening and baseline
History of trial and failure with at least 1 available treatment (topical or other) for AA
History of psychological counseling related to AA
Current episode of severe AA of less than 8 years.
Exclusion Criteria:
LillyTrials@Lilly.com1-317-615-4559
clinical_inquiry_hub@lilly.com
Birmingham, Alabama 35205, United States
205-380-6148
Encinitas, California 92024, United States
San Diego, California 92123, United States
Coral Gables, Florida 33134, United States
Murfreesboro, Tennessee 37130, United States
Ciudad Autonoma Buenos Aires, C1055AA0, Argentina
+541152190541
Ciudad Autonoma Buenos Aires, C1425BEA, Argentina
5491145404544
SAN M. de Tucuman, T4000AXL, Argentina
Wooloongabba, 4102, Australia
730391346
Nantes, 44093, France
Frankfurt am Main, 60590, Germany
Münster, 48149, Germany
Miyagi-gun, 981 0112, Japan
81120023812
Shinjuku-ku, 160-0023, Japan
81120023812
Rzeszów, 35 055, Poland
Swietokrzyski, 27 400, Poland
+48 693 721 891
Cheonan-si, 31116, South Korea
10 9575 5146
Seoul, 06973, South Korea
205-502-9960
480-440-5985
760-203-3839
310-337-7171
858-966-1700 ext. 224295
707-651-1000
714-547-5151
203-785-4632
561-948-3116 x3053
786-698-8508
954-674-3535
904-619-8157
786-585-5774
478-742-2180 ext 255
312-695-3721
847-663-8530
317-516-5030 ext 115
574-204-6192
301-355-3183
248-620-3376
612-625-8625
816-364-1515
402-697-6599
718-920-8352
7042479179 x212
614-725-5010
202-476-3395
216-844-5197
918-392-4550
503-223-1933
843-792-3021
615-410-3460
469-754-1585
972-354-1520
(210) 852-2779 Ext. 1004
281-240-4313
801-587-1948
757-625-0151
608-287-2450
+5491150461624
+5403814200180
5491139842833
+541127690233
+5493815863707
3 9013 0099
412476267
4032633376
(289) 252-1856
905-471-8011
604-953-1333
416-962-0123
204-943-4922
298223333
0491384930
02 40 08 48 86 (84 886)
492036667
+33761453540
33247474625
5922745210
30450518122
3514582007
004969630183115
+49 34196280027
0049-4140-3231
2518357296
+36 30 3005085
+36 72 536 633
81120023812
81120023812
81120023812
81120023812
81120023812
81120023812
587192222
609527827
607566402
790258928
+48 600244514
609279389
605076722
668361281
601316460
48225081482
733240763/ 48510175635
502616031
601534853
51 240 7338
10 5456 7348
32 890 3737
10 3311 8402
10 9268 8342
1066147796
10 5445 9889
2 2030 2845
2 2228 2080
10 6286 2138
10 8948 7721
10 5310 2419
10 9933 0102
934978754
+34 93 2483211
626273207
+34 96 3131800
222490088
910381121
+886 62353535
+886 223562141
228757808
88627135211