Table 2.

Completed or currently active clinical trials involving the use of JAK inhibitors to treat AA.

JAK inhibitor	Study type	Patient information	Dosing	Outcome	End Date	Trial ID	References
Tofacitinib	pilot study, open label	66 adult patients with severe AA, ophiasis, AT, or AU	5 mg twice daily for 3 months	• 42 of 66 patients were responsive. 21 of the responsive patients reached a SALT50 score • Greatest reduction in SALT scores observed in patients with AA (70%) and ophiasis (68%) • 20 patients were followed for 3 months after Tx cessation, and all experienced hair loss • No serious adverse effects (AE) reported	August 2015	NCT02312882 NCT02197455	Kennedy Crispin et al. (63)
Ruxolitinib	Phase 2, open label	12 adult patients with moderate to severe AA	20 mg twice daily for 12-24 weeks	• 9 of 12 patients were responsive, with an average of 92% regrowth • Mean SALT scores of responders: Baseline (65.8), 3 months Tx (24.8), 6 months Tx (7.3) • 3 months after cessation all 9 responders noted hair shedding, with 3 experiencing marked hair loss • No serious AE	April 2016	NCT01950780	Mackay-Wiggan et al. (64)
Delgocitinib ointment (LEO 124249)	Phase 2, double blind, vehicle controlled	31 adult patients with moderate to severe AA (>30% scalp involvement), randomly assigned	30 mg/g ointment applied twice daily (20) or vehicle control (11) for 12 weeks	• The primary outcome measured was change in SALT score. The mean change after 12 weeks of treatment was a decrease of 3.8 in the drug group, and a decrease of 3.4 in the vehicle group. • No serious AE	December 2016	NCT02561585	Mikhaylov et al. (65)
Ruxolitinib cream	Phase 2 Part A: open label Part B: double-blind, placebo controlled, followed with optional open label extension	Part A: 12 adult patients with moderate/severe AA Part B: 78 adults with moderate to severe AA randomly assigned to ruxolitinib (39) or vehicle (39) group Extension: 63 patients, 31 from ruxolitinib group and 32 from vehicle	Part A: 1.5% topical ruxolitinib cream, twice daily for 24 weeks Part B:1.5% topical ruxolitinib cream or vehicle twice daily for 24 weeks Extension: 1.5% topical ruxolitinib, twice daily for 24 weeks	Part A: 6 of 12 patients reached a SALT50 score (50% or greater improvement in SALT score) after 24 weeks of Tx. Part B: 5 of 39 patients in both the Ruxolitinib cream group and the placebo group reached a SALT50 score. Extension: 3 patients from previous ruxolitinib group reached a SALT50 score, and 1 patient reached a SALT90 score. 4 patients from previous vehicle group reached a SALT50 score. • Serious AE experienced by 1 patient in Part A, and 3 patients in Part B	October 2017	NCT02553330	Olsen et al. (66)
Tofacitinib (Xeljanz)	Phase 2, open label	12 adult patients with moderate to severe AA, AT, or AU	5 mg-10 mg twice daily for 6 months with option to extend up to 18 months.	• 11 of 12 patients showed SALT score improvement. Mean SALT score of 81.3 at baseline dropped to 40.8 at the end of treatment. • 8 of 12 patients reached a SALT50 score and were followed for 6 months after Tx cessation. 6 of the 8 experienced hair loss after stopping and 1 patient maintained hair regrowth during this period. • 1 patient experienced AE resulting in discontinuation of Tx	December 2017	NCT02299297	Jabbari et al. (67)
Tofacitinib ointment	Phase 2, open label	10 adult patients with AA (at least 2 patches), AT or AU	2% topical tofacitinib, twice daily to half of affected area for 6 months	• 3 of 10 patients were responsive, with 1 patient experiencing significant regrowth and 2 exhibiting partial regrowth. • Mean SALT score decrease of responsive patients was 34.6% • No serious AE	July 2018	NCT02812342	Liu et al. (68)
Ritlecitinib (PF-06651600)	Phase 2a, double blind with optional single blind extension	72 adult patients with moderate to severe AA. Randomly assigned to ritlecitinib (48) and placebo (24)	200 mg daily for 4 weeks, then 50 mg daily for 20 weeks or placebo	• At 24 weeks of Tx, 50% of patients achieved SALT30 scores, and 25% had achieved SALT90 scores by this time. • No serious AE	May 2019	NCT02974868	King et al. (69)
Brepocitinib (PF-06700841)	Phase 2a, double blind with optional single blind extension	70 adult patients with moderate to severe AA. Randomly assigned to brepocitinib (47) and placebo (23)	60 mg daily for 4 weeks, then 30 mg daily for 20 weeks or placebo	• At 24 weeks of Tx, 64% of patients achieved SALT30 scores, and 34% had achieved SALT90 scores by this time. • 2 patients receiving brepocitinib experienced serious AE	May 2019	NCT02974868	King et al. (69)
ATI-501 JAK1/JAK3 inhibitor	Phase 2, double blind, placebo controlled	87 adult patients with AA, AU, or AT, randomly assigned	400 mg (23), 600 mg (23), 800 mg (22) or placebo (19) taken daily for 24 weeks	• The primary outcome was the percent change in SALT scores. After 24 weeks, changes were: -25.6 (400 mg), -30.4 (600 mg), -25.9 (800 mg), and -6.3 (placebo). • No serious AE	June 2019	NCT03594227	(70)
Ritlecitinib (PF-06651600)	Phase 2B/3, double blind, placebo controlled and dose ranging	718 adult and adolescent (> 12 years old) patients with moderate to severe AA (≥ 50% scalp hair loss)	Range of daily oral dosing, broken into a 4-week loading phase/20-week maintenance phase/24-week extension phase: •200mg/50mg/50mg •200mg/30mg/30mg •50mg/50mg/50mg •30mg/30mg/30mg •10mg/10mg/10mg •placebo	• Primary endpoint was a SALT score ≤ 20. The three highest treatment groups (31%, 22%, and 24% respectively) resulted in the most patients reaching that endpoint. • 30 mg group resulted in 14.5% of patients reaching endpoint, while the 10 mg group only had 2% of patients reach endpoint. • 12 patients, dispersed throughout test groups, experienced serious AE	December 2020	NCT03732807 (ALLEGRO-2b/3)	(71)
Baricitinib (LY3009104)	Phase 3, double blind placebo controlled	654 adult patients with severe AA. (>50% scalp involvement)	4 mg twice daily baracitinib (281), 2 mg twice daily baricitinib (184), or placebo (189)	• The primary outcome was to achieve a SALT score of 20. 38.8% of patients in the 4 mg achieved the outcome, along with 22.8% in the 2 mg group and 6.2% in the placebo group. • Serious AE reported in 13 patients, dispersed throughout all groups	January 2021	NCT03899259 BRAVE-AA2	King et al. (72)
Baricitinib (LY3009104)	Phase 2/3, double blind, placebo controlled	546 adult patients with severe AA (>50% scalp involvement), randomly assigned	4 mg twice daily baracitinib (234), 2 mg twice daily baricitinib (156), or placebo (156)	• The primary outcome was to achieve a SALT score of 20. In the 4 mg group, 35.9% of patients achieved the outcome, along with 19.4% in the 2 mg group and 3.3% in the placebo group. • Serious AE reported in 15 patients, dispersed throughout all groups	February 2021	NCT03570749 BRAVE-AA1	King et al. (72)
CTP-543	Phase 3, double blind, placebo controlled	706 adult patients with severe AA (≥ 50% scalp hair loss), randomly assigned	12 mg CTP-543, 8 mg CTP-543, or a placebo taken twice daily for 24 weeks	• The primary outcome was to achieve a SALT score ≤ 20. 42% of patients in the 12 mg group achieved the outcome, along with 30% in the 8 mg group and 1% in the placebo group. Significant differences noted as early as 8 weeks into Tx. • Serious AE reported in 9 patients dispersed throughout all groups	May 2022	NCT04518995 THRIVE-AA1	(74)
CTP-543	Phase 3, double blind, placebo controlled	517 adult patients with severe AA (≥ 50% scalp hair loss), randomly assigned	12 mg CTP-543, 8 mg CTP-543, or a placebo taken twice daily for 24 weeks	• The primary outcome was to achieve a SALT score ≤ 20. 38.3% of patients in the 12 mg group achieved the primary outcome, along with 33% of patients in the 8 mg group and 0.8% in the placebo group. • Serious AE were experienced by 5 patients in the trial.	June 2022	NCT04797650 THRIVE-AA2	(104)
CTP-543	Phase 2, double blind, placebo controlled	300 adult patients with severe AA (≥ 50% scalp hair loss), randomly assigned	Part A: 12 mg or 8 mg twice daily for 24 weeks, followed by 24 weeks of dose reduction or placebo. Part B: 12 mg or 8 mg twice daily for 24 weeks for patients experiencing loss of maintenance during Part A.	Primary outcome measures: Part A: frequency of patients exhibiting loss of maintenance upon dose reduction or drug discontinuation. Part B: frequency of patients experiencing restoration of regrowth	Est. Oct 2022	NCT04784533	-
Ritlecitinib (PF-06651600)	Phase 3, open label	1049 adult and adolescent (> 12 years old) patients with AA. Some patients have participated in prior PF-066511600 clinical trials.	Naïve patients: 200 mg daily for 1 month, then 50 mg daily for 35 months Previously enrolled patients: 50 mg daily for 36 months	Number of subjects reporting adverse events, abnormal vital signs, or abnormal clinical lab values.	Est. July 2024	NCT04006457 ALLEGRO-LT	-