A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA)
Alopecia Areata
About this trial
This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia Areata, Upadacitinib, Rinvoq, ABT-494
Eligibility Criteria
Inclusion Criteria: Adult individuals < 64 years old at Baseline Visit. Where permitted outside United States (OUS), adolescent individuals who are at least 12 years old at Screening may participate. Diagnosis of severe AA with SALT score ≥ 50 scalp hair loss at Screening and Baseline. Severe AA with no spontaneous scalp hair regrowth over the past 6 months AND no significant scalp hair loss over the past 3 months. Current episode of AA of less than 8 years. Exclusion Criteria: Diagnosis of primarily diffuse type of AA. 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, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.
Sites / Locations
- Advanced Research Associates - Glendale /ID# 259108Recruiting
- Alliance Dermatology and MOHs Center, PC /ID# 258111Recruiting
- Apex Clinical Trials /ID# 259205Recruiting
- Marietta Dermatology Clinical Research /ID# 259818Recruiting
- Michigan Center for Research Company /ID# 258018Recruiting
- Remington-Davis Clinical Research /ID# 258106Recruiting
- Arlington Research Center, Inc /ID# 258028Recruiting
- Center for Clinical Studies /ID# 258036Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Study 1: Group 1 Upadacitinib Dose A
Study 1: Group 2 Upadacitinib Dose B
Study 1: Group 3 Placebo
Study 1: Group 4 Upadacitinib Dose A
Study 1: Group 5 Upadacitinib Dose B
Study 1: Group 6 Placebo
Study 2: Group 1 Upadacitinib Dose A
Study 2: Group 2 Upadacitinib Dose B
Study 2: Group 3 Placebo
Study 2: Group 4 Upadacitinib Dose A
Study 2: Group 5 Upadacitinib Dose B
Study 2: Group 6 Placebo
Study 3: Group 1 Upadacitinib Dose B (SALT > 20)
Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)
Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)
Study 3: Group 4 Upadacitinib Dose B (Sustained)
Study 3: Group 5 Upadacitinib Dose A (Sustained)
Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Participants will receive matching placebo once daily for 24 weeks in Period A.
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 52.
Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Participants will receive matching placebo once daily for 24 weeks in Period A.
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 52.
Participants receiving upadacitinib Dose A with a SALT score > 20 at Week 52 (end of Period B) of Study 1 or Study 2 will dose escalate to upadacitinib Dose B once daily for 108 weeks.
Participants receiving upadacitinib Dose A with a SALT score ≤ 20 at Week 52 (end of Period B) of Study 1 or Study 2 will remain on upadacitinib Dose A once daily for 108 weeks.
Participants who end Period B on upadacitinib Dose B with a with a SALT score > 20 at Week 40 or Week 52 of Study 1 or Study 2 will remain on upadacitinib Dose B once daily for 108 weeks.
Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose B once daily for 108 weeks.
Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose A once daily for 108 weeks.