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A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Upadacitinib

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring ABT-494, Atopic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Atopic dermatitis with a diagnosis confirmed by a dermatologist (according to the Hanifin and Rajka criteria) and onset of symptoms at least 1 year prior to Baseline.
Moderate to severe atopic dermatitis defined by an Eczema Area and Severity Index (EASI) ≥ 16, body surface area (BSA) ≥ 10% and an Investigators Global Assessment (IGA) score ≥ 3 at the Baseline visit.
Documented history (within 1 year prior to the screening visit) of inadequate response to treatment with topical corticosteroids (TCS), or topical calcineurin inhibitors (TCI), or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
Twice daily use of an additive-free, bland emollient for at least 7 days prior to Baseline.

Exclusion Criteria:

Prior exposure to any systemic or topical Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, ruxolitinib, and filgotinib).
Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin within 10 days prior to the Baseline visit.
Prior exposure to dupilumab or exposure to systemic therapies for AD including corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4)-inhibitors and mycophenolate mofetil within 4 weeks prior to Baseline.
Prior exposure to any investigational systemic treatment within 30 days or 5 half-lives (whichever is longer) of the Baseline visit or is currently enrolled in another clinical study.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Upadacitinib 7.5 mg

Upadacitinib 15 mg

Upadacitinib 30 mg

Arm Description

Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo once a day for 72 weeks in Period 2.

Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 7.5 mg upadacitinib or placebo QD for 72 weeks in Period 2.

Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 15 mg upadacitinib or placebo QD for 72 weeks in Period 2.

Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo QD for 72 weeks in Period 2.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from baseline indicates improvement.

Secondary Outcome Measures

Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75) at Week 16

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease. An EASI 75 response is defined as participants with at least a 75% reduction (improvement) in EASI score relative to the Baseline value. Participants with missing values at Week 16 were counted as non-responders in this analysis (non-responder imputation).

Percentage of Participants Achieving an Investigator Global Assessment (IGA) of "0" or "1" at Week 16

The Investigator's Global Assessment for Atopic Dermatitis (IGA) was scored on the following scale: 0: Clear (No inflammatory signs of atopic dermatitis) 1: Almost Clear (Just perceptible erythema and just perceptible papulation/infiltration) 2: Mild (Mild erythema and mild papulation/infiltration) 3: Moderate (Moderate erythema and moderate papulation/infiltration) 4: Severe (Severe erythema and severe papulation/infiltration with or without oozing/crusting) The percentage of participants with a score of 0 or 1 at Week 16 is reported.

Percent Change From Baseline to Weeks 2, 8, and 16 in Pruritus Numerical Rating Scale (NRS)

Percent Change From Baseline in EASI Score at Week 8

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Weeks 8 and 16

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.

Percentage of Participants Who Achieved an EASI 75 Response at Week 8

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease. An EASI 75 response is defined as participants with at least a 75% reduction (improvement) in EASI score relative to the Baseline value. Participants with missing values at Week 8 were counted as non-responders in this analysis (non-responder imputation).

Percentage of Participants Who Achieved an EASI 50 Response at Weeks 8 and 16

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease. An EASI 50 response is defined as participants with at least a 50% reduction (improvement) in EASI score relative to the Baseline value. Participants with missing values at each time point were counted as non-responders in this analysis (non-responder imputation).

Percentage of Participants Who Achieved an EASI 90 Response at Weeks 8 and 16

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease. An EASI 90 response is defined as participants with at least a 90% reduction (improvement) in EASI score relative to the Baseline value. Participants with missing values at each time point were counted as non-responders in this analysis (non-responder imputation).

Percentage of Participants Who Achieved a SCORAD 50 Response at Weeks 8 and 16

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 50 response is defined as participants with at least a 50% reduction (improvement) in SCORAD score relative to the Baseline value. Participants with missing values were counted as non-responders in this analysis (non-responder imputation).

Percentage of Participants Who Achieved a SCORAD 75 Response at Weeks 8 and 16

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 75 response is defined as participants with at least a 75% reduction (improvement) in SCORAD score relative to the Baseline value. Participants with missing values were counted as non-responders in this analysis (non-responder imputation).

Percentage of Participants Who Achieved a SCORAD 90 Response at Weeks 8 and 16

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 90 response is defined as participants with at least a 90% reduction (improvement) in SCORAD score relative to the Baseline value. Participants with missing values were counted as non-responders in this analysis (non-responder imputation).

Percent Change From Re-randomization (Week 16) in EASI Score in Period 2

Time to Loss of EASI 50 Response Relative to Baseline Among Participants Re-randomized as EASI 75 Responders at Week 16

Time to loss of EASI 50 response in Period 2 relative to Baseline among those who were re-randomized as EASI 75 responders at Week 16. Time to loss of EASI 50 response was measured from Week 16 to the date of the first assessment in Period 2 where a participant's EASI score was higher than 50% of their Baseline score. Participants with no loss of response were censored at their last treatment visit or the start of rescue treatment, whichever occurred first.

Percentage of Participants With an EASI 75 Response in Period 2 in Participants Who Were Re-randomized as EASI 75 Non-responders at Week 16

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease. An EASI 75 response is defined as at least a 75% reduction (improvement) in EASI score relative to the Baseline value, and was analyzed in participants who were re-randomized at Week 16 and were EASI 75 non-responders at Week 16.

Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) of "0" or "1" at Weeks 8 and 16

The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A score of 0 or 1 means that the disease has no effect at all. Dermatology Life Quality Index outcomes were defined but are not reported because of an error in the programming of the electronic device used to administer the questionnaire that precluded determination of these outcomes.

Change From Baseline in DLQI at Weeks 8 and 16

The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement. Dermatology Life Quality Index outcomes were defined but are not reported because of an error in the programming of the electronic device used to administer the questionnaire that precluded determination of these outcomes.

Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16

Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA. Last observation carried forward imputation was used.

Percentage of Participants With Reduction of ≥ 4 Points From Baseline in Pruritus NRS at Week 16

Participants were asked to rate pruritus (itch) in the past 24 hours on a daily basis using a scale from 0 to 10, with 0 being no itch and 10 being the worst imaginable itch. The percentage of participants with reduction of ≥ 4 points from Baseline in pruritus NRS was assessed in participants with a baseline pruritus NRS of ≥ 4. Participants with missing values at Week 16 were counted as non-responders in this analysis (non-responder imputation).

Full Information

NCT ID

NCT02925117

First Posted

October 4, 2016

Last Updated

July 1, 2020

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02925117

Brief Title

A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis

Official Title

A Phase 2b Multicenter, Randomized, Placebo-Controlled, Double-Blind Dose-Ranging Study to Evaluate ABT-494 (Upadacitinib) in Adult Subjects With Moderate to Severe Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

October 25, 2016 (Actual)

Primary Completion Date

August 10, 2017 (Actual)

Study Completion Date

January 31, 2019 (Actual)

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

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this study was to evaluate the safety and efficacy of multiple doses of upadacitinib monotherapy versus placebo in the treatment of adults with moderate to severe atopic dermatitis (AD).

Detailed Description

The study was to include a 16-week double-blind treatment period (Period 1) and a 72-week double-blind treatment period (Period 2) for a total of 88 weeks of treatment. Participants who met eligibility criteria were to be randomized in a 1:1:1:1 ratio to one of the four treatment groups. Participants who completed Period 1 were re-randomized at Week 16 into a 72-week double-blind, placebo-controlled treatment period (Period 2) in a 1:1 ratio: Group 1: Upadacitinib 7.5 mg once daily (QD) (Day 1 to Week 16) → upadacitinib 7.5 mg QD or placebo (Week 16 - and thereafter) Group 2: Upadacitinib 15 mg QD (Day 1 to Week 16) → upadacitinib 15 mg QD or placebo (Week 16 and thereafter) Group 3: Upadacitinib 30 mg QD (Day 1 to Week 16) → upadacitinib 30 mg QD or placebo (Week 16 - and thereafter) Group 4: Matching placebo (Day 1 to Week 16) → upadacitinib 30 mg QD or placebo (Week 16 and thereafter) In Period 1, discontinuation from study drug was mandatory for any participant with an Eczema Area and Severity Index (EASI) score worsening of 25% or more compared with their Baseline EASI score at any 2 consecutive scheduled study visits from Week 4 to Week 12. In Period 2, blinded rescue therapy with upadacitinib 30 mg QD was provided after the first instance of a < EASI 50 response starting at the Week 20 visit (4 weeks after re-randomization into Period 2) for the remainder of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

ABT-494, Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

167 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Upadacitinib 7.5 mg

Arm Type

Experimental

Arm Description

Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 7.5 mg upadacitinib or placebo QD for 72 weeks in Period 2.

Arm Title

Upadacitinib 15 mg

Arm Type

Experimental

Arm Description

Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 15 mg upadacitinib or placebo QD for 72 weeks in Period 2.

Arm Title

Upadacitinib 30 mg

Arm Type

Experimental

Arm Description

Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo QD for 72 weeks in Period 2.

Intervention Type

Drug

Intervention Name(s)

Upadacitinib

Other Intervention Name(s)

RINVOQ™, ABT-494

Intervention Description

Tablet for oral use

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Tablet

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16

Description

Time Frame

Baseline and Week 16

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75) at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants Achieving an Investigator Global Assessment (IGA) of "0" or "1" at Week 16

Description

Time Frame

Week 16

Title

Percent Change From Baseline to Weeks 2, 8, and 16 in Pruritus Numerical Rating Scale (NRS)

Description

Time Frame

Baseline and Weeks 2, 8, and 16

Title

Percent Change From Baseline in EASI Score at Week 8

Description

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

Time Frame

Baseline and Week 8

Title

Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Weeks 8 and 16

Description

Time Frame

Baseline and Weeks 8 and 16

Title

Percentage of Participants Who Achieved an EASI 75 Response at Week 8

Description

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease. An EASI 75 response is defined as participants with at least a 75% reduction (improvement) in EASI score relative to the Baseline value. Participants with missing values at Week 8 were counted as non-responders in this analysis (non-responder imputation).

Time Frame

Baseline and Week 8

Title

Percentage of Participants Who Achieved an EASI 50 Response at Weeks 8 and 16

Description

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease. An EASI 50 response is defined as participants with at least a 50% reduction (improvement) in EASI score relative to the Baseline value. Participants with missing values at each time point were counted as non-responders in this analysis (non-responder imputation).

Time Frame

Baseline and Weeks 8 and 16

Title

Percentage of Participants Who Achieved an EASI 90 Response at Weeks 8 and 16

Description

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease. An EASI 90 response is defined as participants with at least a 90% reduction (improvement) in EASI score relative to the Baseline value. Participants with missing values at each time point were counted as non-responders in this analysis (non-responder imputation).

Time Frame

Baseline and Weeks 8 and 16

Title

Percentage of Participants Who Achieved a SCORAD 50 Response at Weeks 8 and 16

Description

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 50 response is defined as participants with at least a 50% reduction (improvement) in SCORAD score relative to the Baseline value. Participants with missing values were counted as non-responders in this analysis (non-responder imputation).

Time Frame

Baseline and Weeks 8 and 16

Title

Percentage of Participants Who Achieved a SCORAD 75 Response at Weeks 8 and 16

Description

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 75 response is defined as participants with at least a 75% reduction (improvement) in SCORAD score relative to the Baseline value. Participants with missing values were counted as non-responders in this analysis (non-responder imputation).

Time Frame

Baseline and Weeks 8 and 16

Title

Percentage of Participants Who Achieved a SCORAD 90 Response at Weeks 8 and 16

Description

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 90 response is defined as participants with at least a 90% reduction (improvement) in SCORAD score relative to the Baseline value. Participants with missing values were counted as non-responders in this analysis (non-responder imputation).

Time Frame

Baseline and Weeks 8 and 16

Title

Percent Change From Re-randomization (Week 16) in EASI Score in Period 2

Description

Time Frame

Re-randomization (Week 16) and Weeks 20, 24, 32, 40, 52, 64, 76, and 88

Title

Time to Loss of EASI 50 Response Relative to Baseline Among Participants Re-randomized as EASI 75 Responders at Week 16

Description

Time Frame

From re-randomization at Week 16 until Week 88

Title

Percentage of Participants With an EASI 75 Response in Period 2 in Participants Who Were Re-randomized as EASI 75 Non-responders at Week 16

Description

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease. An EASI 75 response is defined as at least a 75% reduction (improvement) in EASI score relative to the Baseline value, and was analyzed in participants who were re-randomized at Week 16 and were EASI 75 non-responders at Week 16.

Time Frame

Weeks 20, 24, 32, 40, 52, 64, 76, and 88

Title

Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) of "0" or "1" at Weeks 8 and 16

Description

Time Frame

Weeks 8 and 16

Title

Change From Baseline in DLQI at Weeks 8 and 16

Description

The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement. Dermatology Life Quality Index outcomes were defined but are not reported because of an error in the programming of the electronic device used to administer the questionnaire that precluded determination of these outcomes.

Time Frame

Baseline and Weeks 8 and 16

Title

Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants With Reduction of ≥ 4 Points From Baseline in Pruritus NRS at Week 16

Description

Time Frame

Baseline and Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Atopic dermatitis with a diagnosis confirmed by a dermatologist (according to the Hanifin and Rajka criteria) and onset of symptoms at least 1 year prior to Baseline. Moderate to severe atopic dermatitis defined by an Eczema Area and Severity Index (EASI) ≥ 16, body surface area (BSA) ≥ 10% and an Investigators Global Assessment (IGA) score ≥ 3 at the Baseline visit. Documented history (within 1 year prior to the screening visit) of inadequate response to treatment with topical corticosteroids (TCS), or topical calcineurin inhibitors (TCI), or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks). Twice daily use of an additive-free, bland emollient for at least 7 days prior to Baseline. Exclusion Criteria: Prior exposure to any systemic or topical Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, ruxolitinib, and filgotinib). Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin within 10 days prior to the Baseline visit. Prior exposure to dupilumab or exposure to systemic therapies for AD including corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4)-inhibitors and mycophenolate mofetil within 4 weeks prior to Baseline. Prior exposure to any investigational systemic treatment within 30 days or 5 half-lives (whichever is longer) of the Baseline visit or is currently enrolled in another clinical study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

ForCare Clinical Research /ID# 157974

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613-1244

Country

United States

Facility Name

Advanced Medical Research /ID# 154516

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328-6141

Country

United States

Facility Name

DermAssociates /ID# 153584

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Tufts Medical Center /ID# 153586

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Psoriasis Treatment Ctr NJ /ID# 153578

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

Facility Name

Icahn School of Med Mt. Sinai /ID# 153582

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Univ Rochester Med Ctr /ID# 154477

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Arlington Research Center, Inc /ID# 154522

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

Modern Research Associates, PL /ID# 154487

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Center for Clinical Studies /ID# 153589

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Woden Dermatology /ID# 157907

City

Phillip

State/Province

Australian Capital Territory

ZIP/Postal Code

2606

Country

Australia

Facility Name

St George Hospital /ID# 157908

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Specialist Connect Pty Ltd /ID# 157909

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Skin Health Institute Inc /ID# 157906

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Facility Name

Institute for Skin Advancement /ID# 153246

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3A 2N1

Country

Canada

Facility Name

Dr. Chih-ho Hong Medical Inc. /ID# 153241

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

Enverus Medical Research /ID# 153239

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3V 0C6

Country

Canada

Facility Name

CCA Medical Research /ID# 155817

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1S 7K8

Country

Canada

Facility Name

Lynderm Research Inc. /ID# 153242

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P 1X2

Country

Canada

Facility Name

Dermatology Ottawa Research Centre /ID# 153248

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K2C 3N2

Country

Canada

Facility Name

K. Papp Clinical Research /ID# 153244

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Mehiläinen Neo /ID# 154960

City

Turku

State/Province

Varsinais-Suomi

ZIP/Postal Code

20520

Country

Finland

Facility Name

Mikkeli Central Hospital /ID# 154959

City

Mikkeli

ZIP/Postal Code

50100

Country

Finland

Facility Name

TFS Trial Form Support GmbH /ID# 155442

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Fukuoka University Hospital /ID# 152714

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

Takagi Dermatological Clinic /ID# 152706

City

Obihiro-shi

State/Province

Hokkaido

ZIP/Postal Code

080-0013

Country

Japan

Facility Name

Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 153781

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

060-0063

Country

Japan

Facility Name

Nippon Medical School Hospital /ID# 153287

City

Tokyo

ZIP/Postal Code

113-8602

Country

Japan

Facility Name

Radboud Universitair Medisch Centrum /ID# 153688

City

Nijmegen

State/Province

Gelderland

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Academisch Medisch Centrum /ID# 153596

City

Amsterdam

State/Province

Noord-Holland

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Universitair Medisch Centrum Groningen /ID# 153595

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Universitair Medisch Centrum Utrecht /ID# 153687

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Hospital Santa Creu i Sant Pau /ID# 153519

City

Barcelona

ZIP/Postal Code

08026

Country

Spain

Facility Name

Hospital Univ Germans Trias I /ID# 155598

City

Barcelona

ZIP/Postal Code

08916

Country

Spain

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 and 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

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing URL

https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Citations:

PubMed Identifier

31786154

Citation

Guttman-Yassky E, Thaci D, Pangan AL, Hong HC, Papp KA, Reich K, Beck LA, Mohamed MF, Othman AA, Anderson JK, Gu Y, Teixeira HD, Silverberg JI. Upadacitinib in adults with moderate to severe atopic dermatitis: 16-week results from a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2020 Mar;145(3):877-884. doi: 10.1016/j.jaci.2019.11.025. Epub 2019 Nov 29.

Results Reference

result

Learn more about this trial

A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis

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A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial