Evaluating the Effectiveness and Tolerance of Baricitinib in the Treatment of Acute Alopecia Areata With Active Hair Shedding: A Prospective Open-Label Study (MQ7422)

Inclusion Criteria:

1. Subjects must be between 18 and 65 years of age (inclusive) at the time of enrollment. Subjects are eligible if they are male or nonpregnant, nonbreastfeeding female patients.
2. Active AA is defined as 30% or more of scalp surface area with active shedding via pull test
3. Current AA episode onset within 3 months

Exclusion Criteria:

1. Causes of acute hair shedding other than AA;
2. AA, in which the activity and/or onset time cannot be accurately determined;
3. Other medical concomitant conditions that require the use of systemic corticosteroids or immunosuppressants within 8 weeks of the baseline visit;
4. Intralesional steroid injection for AA within 4 weeks;
5. Previous treatment with oral JAKi with an inadequate response;
6. Have evidence of active TB or latent TB without completing at least 4 weeks of appropriate treatment;
7. Have any of the following specific abnormalities on screening laboratory tests: ANC <1,000 cells/mm³; ALC <500 cells/mm³; Hb levels <8 g/dL, platelets <100,000 cells/μL; AST or ALT ≥2 × ULN; ALP ≥2 × ULN; TBL ≥1.5 × ULN; eGFR <60 mL/min/1.73m2
8. Have an active, serious infection, including localized infection;
9. Have had symptomatic herpes zoster infection within 12 weeks before randomization. Have a history of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement);
10. Have a positive test for hepatitis B virus (HBV) infection, defined as positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) and positive HBV deoxyribonucleic acid (DNA).
11. Have hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid [RNA]-positive);
12. Have evidence of HIV infection and/or positive HIV antibodies;
13. Have been exposed to a live vaccine within 12 weeks or are expected to need/receive a live vaccine during the course of the study (except herpes zoster vaccination);
14. Have a history of chronic alcohol abuse, intravenous drug abuse, or other illicit drug abuse within the 2 years before study entry;
15. Have a history of cancer, or have an active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years (except fully treated NMSC and SCCis of the cervix). Have a history of lymphoproliferative disease; have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly;
16. Have experienced any of the following within 12 weeks of screening: VTE (DVT/pulmonary embolism [PE]), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure;
17. Have had any major surgery within 8 weeks before screening or will require major surgery during the study that, in the opinion of the investigator would pose an unacceptable risk to the patient;
18. Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that in the opinion of the investigator, could constitute an unacceptable risk when taking the investigational product or interfere with the interpretation of data;
19. Any other condition in the opinion of the investigator which would interfere with the study assessments or procedure.