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

Primary Purpose

Alopecia Areata

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Upadacitinib
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia Areata, Upadacitinib, Rinvoq, ABT-494

Eligibility Criteria

12 Years - 63 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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)

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20
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

Percentage of Participants with the Achievement of SALT Score <= 10
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%.
Percentage of Participants with the Achievement of SALT Score <= 20
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%.
Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1
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.
Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1
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.
Percentage of Participants with the Achievement of SALT 75
SALT 75 is defined as at least a 75% improvement [decrease] from Baseline in SALT score.
Percentage of Participants with the Achievement of SALT 90
SALT 90 is defined as at least a 90% improvement [decrease] from Baseline in SALT score.
Percent Change from Baseline in SALT Score
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%.
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"
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."
Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment 0/1 with ≥ 2-Point Improvement (Reduction)
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.
Percentage of Participants with the Achievement of SALT Score 0
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%.

Full Information

First Posted
August 22, 2023
Last Updated
October 23, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT06012240
Brief Title
A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2023 (Actual)
Primary Completion Date
May 26, 2025 (Anticipated)
Study Completion Date
January 3, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia Areata, Upadacitinib, Rinvoq, ABT-494

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study 1: Group 1 Upadacitinib Dose A
Arm Type
Experimental
Arm Description
Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Arm Title
Study 1: Group 2 Upadacitinib Dose B
Arm Type
Experimental
Arm Description
Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Arm Title
Study 1: Group 3 Placebo
Arm Type
Experimental
Arm Description
Participants will receive matching placebo once daily for 24 weeks in Period A.
Arm Title
Study 1: Group 4 Upadacitinib Dose A
Arm Type
Experimental
Arm Description
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.
Arm Title
Study 1: Group 5 Upadacitinib Dose B
Arm Type
Experimental
Arm Description
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.
Arm Title
Study 1: Group 6 Placebo
Arm Type
Experimental
Arm Description
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 52.
Arm Title
Study 2: Group 1 Upadacitinib Dose A
Arm Type
Experimental
Arm Description
Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Arm Title
Study 2: Group 2 Upadacitinib Dose B
Arm Type
Experimental
Arm Description
Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Arm Title
Study 2: Group 3 Placebo
Arm Type
Experimental
Arm Description
Participants will receive matching placebo once daily for 24 weeks in Period A.
Arm Title
Study 2: Group 4 Upadacitinib Dose A
Arm Type
Experimental
Arm Description
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.
Arm Title
Study 2: Group 5 Upadacitinib Dose B
Arm Type
Experimental
Arm Description
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.
Arm Title
Study 2: Group 6 Placebo
Arm Type
Experimental
Arm Description
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 52.
Arm Title
Study 3: Group 1 Upadacitinib Dose B (SALT > 20)
Arm Type
Experimental
Arm Description
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.
Arm Title
Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)
Arm Type
Experimental
Arm Description
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.
Arm Title
Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)
Arm Type
Experimental
Arm Description
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.
Arm Title
Study 3: Group 4 Upadacitinib Dose B (Sustained)
Arm Type
Experimental
Arm Description
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.
Arm Title
Study 3: Group 5 Upadacitinib Dose A (Sustained)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
Rinvoq, ABT-494
Intervention Description
Oral Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Tablets
Primary Outcome Measure Information:
Title
Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20
Description
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%.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants with the Achievement of SALT Score <= 10
Description
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%.
Time Frame
Week 24
Title
Percentage of Participants with the Achievement of SALT Score <= 20
Description
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%.
Time Frame
Up to Week 12
Title
Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1
Description
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.
Time Frame
Baseline to Week 24
Title
Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1
Description
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.
Time Frame
Baseline to Week 24
Title
Percentage of Participants with the Achievement of SALT 75
Description
SALT 75 is defined as at least a 75% improvement [decrease] from Baseline in SALT score.
Time Frame
Baseline to Week 24
Title
Percentage of Participants with the Achievement of SALT 90
Description
SALT 90 is defined as at least a 90% improvement [decrease] from Baseline in SALT score.
Time Frame
Baseline to Week 24
Title
Percent Change from Baseline in SALT Score
Description
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%.
Time Frame
Baseline to Week 24
Title
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"
Description
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."
Time Frame
Up to Week 24
Title
Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment 0/1 with ≥ 2-Point Improvement (Reduction)
Description
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.
Time Frame
Baseline to Week 24
Title
Percentage of Participants with the Achievement of SALT Score 0
Description
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%.
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Research Associates - Glendale /ID# 259108
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance Dermatology and MOHs Center, PC /ID# 258111
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Name
Apex Clinical Trials /ID# 259205
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+1-813-321-1786
Facility Name
Marietta Dermatology Clinical Research /ID# 259818
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060-1047
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Center for Research Company /ID# 258018
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Individual Site Status
Recruiting
Facility Name
Remington-Davis Clinical Research /ID# 258106
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Name
Arlington Research Center, Inc /ID# 258028
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Clinical Studies /ID# 258036
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M23-716
Description
Related Info

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A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

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