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

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ClinicalTrials.gov Identifier: NCT02925117
Recruitment Status : Active, not recruiting
First Posted : October 5, 2016
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is an 88-week Phase 2b, randomized, double-blind, parallel-group, placebo-controlled multicenter study to evaluate the safety and efficacy of ABT-494 (upadacitinib) in adult subjects with moderate to severe atopic dermatitis. In Period 1, subjects will be randomized in a 1:1:1:1 ratio to one of four treatment groups.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: ABT-494 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 25, 2016
Actual Primary Completion Date : August 10, 2017
Estimated Study Completion Date : January 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: Participants receiving Dose A
Participants receiving Dose A once daily (QD) for 16 weeks
Drug: ABT-494
Oral tablet
Other Name: Upadacitinib

Active Comparator: Participants receiving Dose C
Participants receiving Dose C once daily (QD) for 16 weeks
Drug: ABT-494
Oral tablet
Other Name: Upadacitinib

Placebo Comparator: Participants receiving matching placebo
Participants receiving matching placebo for 16 weeks
Drug: Placebo
Oral tablet

Active Comparator: Participants receiving Dose B
Participants receiving Dose B once daily (QD) for 16 weeks
Drug: ABT-494
Oral tablet
Other Name: Upadacitinib




Primary Outcome Measures :
  1. Mean Percentage Change in EASI score [ Time Frame: At Week 16 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.


Secondary Outcome Measures :
  1. Percent change in EASI score [ Time Frame: From Day 1 (baseline) and Week 8 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.

  2. Proportion of participants achieving EASI 75 response [ Time Frame: Up to Week 16 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.

  3. Proportion of participants achieving EASI 90 response [ Time Frame: Up to Week 16 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.

  4. Proportion of participants achieving SCORAD 90 response [ Time Frame: Up to Week 16 ]
    The SCORAD is a tool used in clinical research and clinical practice that was developed to standardize the evaluation of the extent and severity of Atopic Dermatitis (AD).

  5. Proportion of participants achieving SCORAD 50 response [ Time Frame: Up to Week 16 ]
    The SCORAD is a tool used in clinical research and clinical practice that was developed to standardize the evaluation of the extent and severity of Atopic Dermatitis (AD).

  6. Summary of EASI 75 at all visits in Period 2 among those who were re-randomized as EASI 75 non-responders at Week 16 [ Time Frame: Up to Week 88 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.

  7. Proportion of participants with Dermatology Life Quality Index (DLQI) = "0" or "1" [ Time Frame: Up to Week 16 ]
    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.

  8. Proportion of participants achieving SCORAD 75 response [ Time Frame: Up to Week 16 ]
    The SCORAD is a tool used in clinical research and clinical practice that was developed to standardize the evaluation of the extent and severity of Atopic Dermatitis (AD).

  9. Percent change in SCORAD score [ Time Frame: From Day 1 to Week 16 ]
    The SCORAD is a tool used in clinical research and clinical practice that was developed to standardize the evaluation of the extent and severity of Atopic Dermatitis (AD).

  10. Time to loss of EASI 50 response relative to Baseline among those who were re-randomized as EASI 75 responders at Week 16 [ Time Frame: Up to Week 88 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.

  11. Change and percent change from Week 16 (re-randomization) in EASI score at all Period 2 visits [ Time Frame: Up to Week 88 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.

  12. Proportion of participants achieving EASI 50 response [ Time Frame: Up to Week 16 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.

  13. Percent change in pruritus/ itch numerical rating scale (NRS) [ Time Frame: From Day 1 (Baseline) to Week 16 ]
    Itch will be rated from 0 (no itch) to 10 (worst imaginable itch).

  14. Proportion of participants achieving an Investigator Global Assessment (IGA) of "0" or "1" [ Time Frame: At Week 16 ]
    The Investigators's Global Assessment (IGA) is a 5-point scale used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 (clear, no inflammatory signs of AD) to 4 (severe, Severe erythema and severe papulation/infiltration with or without oozing/crusting).

  15. Change from Baseline in DLQI [ Time Frame: From Day 1 to Week 16 ]
    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.

  16. Proportion of Participants achieving an EASI 75 response [ Time Frame: At Week 16 ]
    It is defined as at least a 75% reduction in EASI score relative to the baseline (day 1)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925117


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Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02925117     History of Changes
Other Study ID Numbers: M16-048
2016-002451-21 ( EudraCT Number )
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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.: No

Keywords provided by AbbVie:
ABT-494
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases