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Atopic DermatitisPhase 2NCT02925117

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

A Phase 2 study testing Upadacitinib in people with Atopic Dermatitis, run by AbbVie at 34 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
167 participants
Where
34 sitesin 8 countries
Study dates
25 Oct 2016to 31 Jan 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

34 sites in 8 countries.

34 sites in 8 countries

United States10 sites

  • Arlington Research Center, Inc /ID# 154522

    Arlington, Texas, 76011

  • Tufts Medical Center /ID# 153586

    Boston, Massachusetts, 02111

  • Modern Research Associates, PL /ID# 154487

    Dallas, Texas, 75231

  • Psoriasis Treatment Ctr NJ /ID# 153578

    East Windsor, New Jersey, 08520

  • Center for Clinical Studies /ID# 153589

    Houston, Texas, 77004

  • Icahn School of Med Mt. Sinai /ID# 153582

    New York, New York, 10029

  • Univ Rochester Med Ctr /ID# 154477

    Rochester, New York, 14642

  • DermAssociates /ID# 153584

    Rockville, Maryland, 20850

  • Advanced Medical Research /ID# 154516

    Sandy Springs, Georgia, 30328-6141

  • ForCare Clinical Research /ID# 157974

    Tampa, Florida, 33613-1244

Other trials in United States

Canada7 sites

  • CCA Medical Research /ID# 155817

    Ajax, Ontario, L1S 7K8

  • Institute for Skin Advancement /ID# 153246

    Calgary, Alberta, T3A 2N1

  • Lynderm Research Inc. /ID# 153242

    Markham, Ontario, L3P 1X2

  • Dermatology Ottawa Research Centre /ID# 153248

    Ottawa, Ontario, K2C 3N2

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

    Surrey, British Columbia, V3R 6A7

  • Enverus Medical Research /ID# 153239

    Surrey, British Columbia, V3V 0C6

  • K. Papp Clinical Research /ID# 153244

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Australia4 sites

  • Skin Health Institute Inc /ID# 157906

    Carlton, Victoria, 3053

  • St George Hospital /ID# 157908

    Kogarah, New South Wales, 2217

  • Woden Dermatology /ID# 157907

    Phillip, Australian Capital Territory, 2606

  • Specialist Connect Pty Ltd /ID# 157909

    Woolloongabba, Queensland, 4102

Other trials in Australia

Japan4 sites

  • Fukuoka University Hospital /ID# 152714

    Fukuoka, Fukuoka, 814-0180

  • Takagi Dermatological Clinic /ID# 152706

    Obihiro-shi, Hokkaido, 080-0013

  • Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 153781

    Sapporo, Hokkaido, 060-0063

  • Nippon Medical School Hospital /ID# 153287

    Tokyo, 113-8602

Other trials in Japan

Netherlands4 sites

  • Academisch Medisch Centrum /ID# 153596

    Amsterdam, North Holland, 1105 AZ

  • Universitair Medisch Centrum Groningen /ID# 153595

    Groningen, 9713 GZ

  • Radboud Universitair Medisch Centrum /ID# 153688

    Nijmegen, Gelderland, 6525 GA

  • Universitair Medisch Centrum Utrecht /ID# 153687

    Utrecht, 3584 CX

Other trials in Netherlands

Finland2 sites

  • Mikkeli Central Hospital /ID# 154959

    Mikkeli, 50100

  • Mehiläinen Neo /ID# 154960

    Turku, Southwest Finland, 20520

Other trials in Finland

Spain2 sites

  • Hospital Santa Creu i Sant Pau /ID# 153519

    Barcelona, 08026

  • Hospital Univ Germans Trias I /ID# 155598

    Barcelona, 08916

Other trials in Spain

Germany1 site

  • TFS Trial Form Support GmbH /ID# 155442

    Hamburg, 20354

Other trials in Germany

About this study

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

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).

Read the 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.

Being tested
Upadacitinib, Placebo
Keywords
ABT-494, Atopic Dermatitis
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UpadacitinibDrug

    Also called RINVOQ™, ABT-494

    Tablet for oral use

  • PlaceboDrug

    Tablet

Study groups in NCT02925117
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Upadacitinib; Drug: Placebo
Upadacitinib 7.5 mgExperimentalParticipants 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.
Receives: Drug: Upadacitinib; Drug: Placebo
Upadacitinib 15 mgExperimentalParticipants 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.
Receives: Drug: Upadacitinib; Drug: Placebo
Upadacitinib 30 mgExperimentalParticipants 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.
Receives: Drug: Upadacitinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 16

Secondary outcomes (18)

  1. 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).

    Measured: Baseline and Week 16

  2. 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.

    Measured: Week 16

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

    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 percent change from Baseline at each week was calculated from a rolling weekly average.

    Measured: Baseline and Weeks 2, 8, and 16

  4. 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.

    Measured: Baseline and Week 8

  5. 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.

    Measured: Baseline and Weeks 8 and 16

  6. 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).

    Measured: Baseline and Week 8

  7. 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).

    Measured: Baseline and Weeks 8 and 16

  8. 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).

    Measured: Baseline and Weeks 8 and 16

  9. 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).

    Measured: Baseline and Weeks 8 and 16

  10. 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).

    Measured: Baseline and Weeks 8 and 16

  11. 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).

    Measured: Baseline and Weeks 8 and 16

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

    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.

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

  13. 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.

    Measured: From re-randomization at Week 16 until Week 88

  14. 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.

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

  15. 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.

    Measured: Weeks 8 and 16

  16. 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.

    Measured: Baseline and Weeks 8 and 16

  17. 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.

    Measured: Baseline and Week 16

  18. 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).

    Measured: Baseline and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2016 (estimated)
  2. Study start25 Oct 2016
  3. Primary completion10 Aug 2017
  4. Study completion31 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02925117
Sponsor's protocol ID
M16-048
Other IDs
2016-002451-21, 2016
Status last verified
Jul 2020
First submitted
4 Oct 2016
Last updated
16 Jul 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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 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.

Publications

  • 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.

    PubMed 31786154

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Upadacitinib in people with Atopic Dermatitis, run by AbbVie at 34 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Canada, Australia, Japan, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02925117, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.

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