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Clinical Trials List

Protocol NumberM23-716

NCT Number(ClinicalTrials.gov Identfier)NCT06012240

Active

2024-01-01 - 2028-04-30

Phase III

Recruiting5

ICD-10L63.2

Ophiasis

ICD-10L63.8

Other alopecia areata

ICD-10L63.9

Alopecia areata, unspecified

ICD-9704.01

Alopecia areata

A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata

Trial Applicant

AbbVie
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/06/18

Investigators and Locations

Principal Investigator

National Taiwan University Hospital

Co-Principal Investigator

陳柏樺

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

Taipei Veterans General Hospital

Co-Principal Investigator

Yun-Ting Chang 無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Huei Huang 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Chun Yang

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Alopecia Areata

Objectives

Objectives: Trials 1 and 2, Double-blind period, baseline to week 24 (Phase A): • Evaluate the efficacy, safety, and tolerability of upadacitinib 15 mg once daily (QD) and 30 mg QD compared to placebo in adult or adolescent (outside the United States [OUS], if permitted) and adult subjects for the treatment of signs and symptoms of severe AA. Double-blinded extension period, week 24 to week 52 (Phase B): • Evaluate the efficacy, safety, and tolerability of extended treatment with upadacitinib 15 mg QD and 30 mg QD in adult or adolescent (outside the United States [OUS], if permitted) and adult subjects with severe AA. Trial 3, Re-randomized double-blinded extension period, week 52 to week 160: • In adult or adolescent (outside the United States [OUS], if permitted) subjects with severe AA. In adolescents (OUS, if permitted) and adult subjects, evaluate the long-term safety and efficacy of the following treatments: • Continuous upadacitinib 30 mg QD treatment • In subjects who achieved a durable response in Trial 1 or Trial 2 (defined as a Severity of Hair Loss Tool (SALT) score ≤ 20 at weeks 40 and 52), reduce the dose to 15 mg QD • Continuous upadacitinib 15 mg QD treatment • In subjects who did not achieve a SALT score ≤ 20 at week 52 in Trial 1 or Trial 2, or who lost a response during Trial 3, increase the dose to 30 mg QD. Primary endpoint: Trial 1 and Trial 2: The primary endpoint was achieving a SALT score ≤ 20 at week 24, defined as less than or equal to 20% scalp hair loss.

Test Drug

N/A
N/A

Active Ingredient

9200090300

Dosage Form

N/A
N/A

Dosage

-

Endpoints

The primary indicator was a SALT score of ≤20 at week 24, defined as scalp hair loss of ≤20%.

Inclution Criteria

Inclusion Criteria:

Adult individuals must be < 64 years old at Baseline Visit. Where permitted outside United States (US)/European Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4.
Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score >= 50 scalp hair loss at Screening and Baseline.
Severe AA with no spontaneous scalp hair regrowth over the past 6 months.
Current episode of AA of less than 8 years.

Exclusion Criteria

Exclusion Criteria:

Current diagnosis of primarily diffuse type of AA.
Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.
Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.

The Estimated Number of Participants

Taiwan

30 participants
Global

1200 participants