History of Changes for Study: NCT06012240

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA)

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Study Record Versions

Version	Submitted Date	Changes
1	August 22, 2023	None (earliest Version on record)
2	September 26, 2023	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	October 2, 2023	Study Status and Contacts/Locations
4	October 16, 2023	Study Status and Contacts/Locations
5	October 19, 2023	Contacts/Locations and Study Status
6	October 23, 2023	Contacts/Locations and Study Status
7	October 24, 2023	Contacts/Locations and Study Status
8	October 30, 2023	Contacts/Locations and Study Status
9	October 31, 2023	Contacts/Locations and Study Status
10	November 1, 2023	Study Status and Contacts/Locations
11	November 6, 2023	Contacts/Locations and Study Status
12	November 7, 2023	Contacts/Locations and Study Status
13	November 8, 2023	Contacts/Locations and Study Status
14	November 9, 2023	Contacts/Locations and Study Status
15	November 15, 2023	Contacts/Locations and Study Status
16	November 21, 2023	Contacts/Locations and Study Status
17	November 23, 2023	Contacts/Locations and Study Status
18	November 27, 2023	Contacts/Locations and Study Status
19	November 29, 2023	Contacts/Locations and Study Status
20	December 11, 2023	Study Status and Contacts/Locations
21	December 14, 2023	Contacts/Locations and Study Status
22	December 18, 2023	Contacts/Locations and Study Status
23	December 20, 2023	Contacts/Locations and Study Status
24	December 21, 2023	Contacts/Locations and Study Status
25	December 22, 2023	Contacts/Locations and Study Status
26	December 28, 2023	Contacts/Locations and Study Status
27	January 3, 2024	Study Status
28	January 4, 2024	Contacts/Locations and Study Status
29	January 9, 2024	Contacts/Locations and Study Status
30	January 10, 2024	Study Status
31	January 11, 2024	Contacts/Locations and Study Status
32	January 15, 2024	Contacts/Locations and Study Status
33	January 18, 2024	Contacts/Locations and Study Status
34	January 22, 2024	Contacts/Locations and Study Status
35	January 22, 2024	Contacts/Locations and Study Status
36	January 25, 2024	Contacts/Locations and Study Status
37	January 29, 2024	Contacts/Locations and Study Status
38	February 1, 2024	Contacts/Locations and Study Status
39	February 2, 2024	Contacts/Locations and Study Status
40	February 6, 2024	Contacts/Locations and Study Status
41	February 8, 2024	Contacts/Locations and Study Status
42	February 9, 2024	Contacts/Locations and Study Status
43	February 19, 2024	Contacts/Locations and Study Status
44	February 21, 2024	Study Status
45	February 22, 2024	Contacts/Locations and Study Status
46	February 23, 2024	Contacts/Locations and Study Status
47	February 27, 2024	Contacts/Locations and Study Status
48	February 28, 2024	Contacts/Locations and Study Status
49	March 1, 2024	Study Status and Contacts/Locations
50	March 5, 2024	Study Status
51	March 6, 2024	Contacts/Locations and Study Status
52	April 23, 2024	Contacts/Locations, Study Status, Eligibility, Outcome Measures and Arms and Interventions
53	April 24, 2024	Contacts/Locations and Study Status
54	April 25, 2024	Study Status and Contacts/Locations
55	April 26, 2024	Contacts/Locations and Study Status
56	April 30, 2024	Contacts/Locations and Study Status
57	May 1, 2024	Study Status and Contacts/Locations
58	May 2, 2024	Contacts/Locations and Study Status
59	May 8, 2024	Contacts/Locations and Study Status
60	May 9, 2024	Contacts/Locations and Study Status
61	May 13, 2024	Contacts/Locations and Study Status
62	May 13, 2024	Study Status
63	May 14, 2024	Contacts/Locations and Study Status
64	May 15, 2024	Contacts/Locations and Study Status
65	May 20, 2024	Contacts/Locations and Study Status
66	May 20, 2024	Contacts/Locations and Study Status
67	May 22, 2024	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	M23-716
Brief Title:	A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA)
Official Title:	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
Secondary IDs:	2023-505061-82-00 [EU CT]

Study Status


Record Verification:	August 2023
Overall Status:	Not yet recruiting
Study Start:	October 26, 2023
Primary Completion:	May 26, 2025 [Anticipated]
Study Completion:	January 3, 2028 [Anticipated]

First Submitted:	August 22, 2023
First Submitted that Met QC Criteria:	August 22, 2023
First Posted:	August 25, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	August 22, 2023
Last Update Posted:	August 25, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	AbbVie
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

Brief Summary:

Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.

Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1 or Study 2, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 240 sites worldwide.

Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Detailed Description:

Conditions


Conditions:	Alopecia Areata
Keywords:	Alopecia Areata Upadacitinib Rinvoq ABT-494

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Sequential Assignment
Number of Arms:	17
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	1500 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Study 1: Group 1 Upadacitinib Dose A Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.	Drug: Upadacitinib Oral Tablets Other Names: Rinvoq ABT-494
Experimental: Study 1: Group 2 Upadacitinib Dose B Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.	Drug: Upadacitinib Oral Tablets Other Names: Rinvoq ABT-494
Experimental: Study 1: Group 3 Placebo Participants will receive matching placebo once daily for 24 weeks in Period A.	Drug: Placebo Oral Tablets
Experimental: Study 1: Group 4 Upadacitinib Dose 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.	Drug: Upadacitinib Oral Tablets Other Names: Rinvoq ABT-494 Drug: Placebo Oral Tablets
Experimental: Study 1: Group 5 Upadacitinib Dose 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.	Drug: Upadacitinib Oral Tablets Other Names: Rinvoq ABT-494 Drug: Placebo Oral Tablets
Experimental: Study 1: Group 6 Placebo Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 52.	Drug: Placebo Oral Tablets
Experimental: Study 2: Group 1 Upadacitinib Dose A Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.	Drug: Upadacitinib Oral Tablets Other Names: Rinvoq ABT-494
Experimental: Study 2: Group 2 Upadacitinib Dose B Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.	Drug: Upadacitinib Oral Tablets Other Names: Rinvoq ABT-494
Experimental: Study 2: Group 3 Placebo Participants will receive matching placebo once daily for 24 weeks in Period A.	Drug: Placebo Oral Tablets
Experimental: Study 2: Group 4 Upadacitinib Dose 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.	Drug: Upadacitinib Oral Tablets Other Names: Rinvoq ABT-494 Drug: Placebo Oral Tablets
Experimental: Study 2: Group 5 Upadacitinib Dose 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.	Drug: Upadacitinib Oral Tablets Other Names: Rinvoq ABT-494 Drug: Placebo Oral Tablets
Experimental: Study 2: Group 6 Placebo Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 52.	Drug: Placebo Oral Tablets
Experimental: Study 3: Group 1 Upadacitinib Dose B (SALT > 20) 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.	Drug: Upadacitinib Oral Tablets Other Names: Rinvoq ABT-494
Experimental: Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20) 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.	Drug: Upadacitinib Oral Tablets Other Names: Rinvoq ABT-494
Experimental: Study 3: Group 3 Upadacitinib Dose B (Non-Sustained) 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.	Drug: Upadacitinib Oral Tablets Other Names: Rinvoq ABT-494
Experimental: Study 3: Group 4 Upadacitinib Dose B (Sustained) 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.	Drug: Upadacitinib Oral Tablets Other Names: Rinvoq ABT-494
Experimental: Study 3: Group 5 Upadacitinib Dose A (Sustained) 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.	Drug: Upadacitinib Oral Tablets Other Names: Rinvoq ABT-494

Outcome Measures


Primary Outcome Measures:
1.	Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20 [ Time Frame: Week 24 ] The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
Secondary Outcome Measures:
1.	Percentage of Participants with the Achievement of SALT Score <= 10 [ Time Frame: Week 24 ] The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
2.	Percentage of Participants with the Achievement of SALT Score <= 20 [ Time Frame: Up to Week 12 ] The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
3.	Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1 [ Time Frame: Baseline to Week 24 ] The ClinRO for Eyebrow Hair Loss is a 4-point response scale where 0 = The eyebrows have full coverage and no areas of hair loss and 3 = No notable eyebrows. Responses should have a ≥ 2-point improvement from Baseline among participants with Baseline score ≥ 2.
4.	Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1 [ Time Frame: Baseline to Week 24 ] The ClinRO for Eyebrow Hair Loss is a 4-point response scale where 0 = The eyelashes form a continuous line along the eyelids on both eyes and 3 = No notable eyelashes. Responses should have a ≥ 2-point improvement from Baseline among participants with Baseline score ≥ 2.
5.	Percentage of Participants with the Achievement of SALT 75 [ Time Frame: Baseline to Week 24 ] SALT 75 is defined as at least a 75% improvement [decrease] from Baseline in SALT score.
6.	Percentage of Participants with the Achievement of SALT 90 [ Time Frame: Baseline to Week 24 ] SALT 90 is defined as at least a 90% improvement [decrease] from Baseline in SALT score.
7.	Percent Change from Baseline in SALT Score [ Time Frame: Baseline to Week 24 ] The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
8.	Percentage of Participants with the Achievement of Patients' Global Impression of Change of Alopecia Areata (PaGIC-AA) Score of 1 "Much Better" or 2 "Moderately Better" [ Time Frame: Up to Week 24 ] The PaGIC-AA is a single-item measure that asks participants to rate how their alopecia condition has changed overall since the start of the study using a 7-point scale. Responses range from "much better" to "much worse."
9.	Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment 0/1 with ≥ 2-Point Improvement (Reduction) [ Time Frame: Baseline to Week 24 ] The PRO for Scalp Hair Assessment is single item, five-point, categorical response scale that asks respondents to look in the mirror and assess the total area of the scalp with missing hair. Response items range from "No missing hair" to "Nearly all or all" and includes percentage ranges for each category (0%, 1 to 20%, 21 to 49%, 50 to 94%, and 95 to 100%). Responses among participants with baseline score >=3.
10.	Percentage of Participants with the Achievement of SALT Score 0 [ Time Frame: Week 24 ] The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.

Eligibility


Minimum Age:	12 Years
Maximum Age:	63 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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.

Contacts/Locations


Central Contact Person:	ABBVIE CALL CENTER Telephone: 844-663-3742 Email: abbvieclinicaltrials@abbvie.com
Study Officials:	ABBVIE INC. Study Director AbbVie
Locations:

IPDSharing


Plan to Share IPD:	Yes AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR)
	Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
	Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
	URL: https://vivli.org/ourmember/abbvie/

References


Citations:
Links:	URL: https://www.abbvieclinicaltrials.com/study/?id=M23-716 Description: Related Info
Available IPD/Information: