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

July 1, 2020 updated by: AbbVie

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Woden Dermatology /ID# 157907
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital /ID# 157908
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Specialist Connect Pty Ltd /ID# 157909
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Skin Health Institute Inc /ID# 157906
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3A 2N1
        • Institute for Skin Advancement /ID# 153246
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Dr. Chih-ho Hong Medical Inc. /ID# 153241
      • Surrey, British Columbia, Canada, V3V 0C6
        • Enverus Medical Research /ID# 153239
    • Ontario
      • Ajax, Ontario, Canada, L1S 7K8
        • CCA Medical Research /ID# 155817
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc. /ID# 153242
      • Ottawa, Ontario, Canada, K2C 3N2
        • Dermatology Ottawa Research Centre /ID# 153248
      • Waterloo, Ontario, Canada, N2J 1C4
        • K. Papp Clinical Research /ID# 153244
  • Finland
      • Mikkeli, Finland, 50100
        • Mikkeli Central Hospital /ID# 154959
    • Varsinais-Suomi
      • Turku, Varsinais-Suomi, Finland, 20520
        • Mehiläinen Neo /ID# 154960
  • Germany
      • Hamburg, Germany, 20354
        • TFS Trial Form Support GmbH /ID# 155442
  • Japan
      • Tokyo, Japan, 113-8602
        • Nippon Medical School Hospital /ID# 153287
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital /ID# 152714
    • Hokkaido
      • Obihiro-shi, Hokkaido, Japan, 080-0013
        • Takagi Dermatological Clinic /ID# 152706
      • Sapporo-shi, Hokkaido, Japan, 060-0063
        • Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 153781
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen /ID# 153595
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht /ID# 153687
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboud Universitair Medisch Centrum /ID# 153688
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Academisch Medisch Centrum /ID# 153596
  • Spain
      • Barcelona, Spain, 08026
        • Hospital Santa Creu i Sant Pau /ID# 153519
      • Barcelona, Spain, 08916
        • Hospital Univ Germans Trias I /ID# 155598
  • United States
    • Florida
      • Tampa, Florida, United States, 33613-1244
        • ForCare Clinical Research /ID# 157974
    • Georgia
      • Sandy Springs, Georgia, United States, 30328-6141
        • Advanced Medical Research /ID# 154516
    • Maryland
      • Rockville, Maryland, United States, 20850
        • DermAssociates /ID# 153584
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center /ID# 153586
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Psoriasis Treatment Ctr NJ /ID# 153578
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Med Mt. Sinai /ID# 153582
      • Rochester, New York, United States, 14642
        • Univ Rochester Med Ctr /ID# 154477
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center, Inc /ID# 154522
      • Dallas, Texas, United States, 75231
        • Modern Research Associates, PL /ID# 154487
      • Houston, Texas, United States, 77004
        • Center for Clinical Studies /ID# 153589

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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.
Drug: Placebo
Tablet
Drug: Upadacitinib
Tablet for oral use
Other Names:
  • ABT-494
  • RINVOQ™
Experimental: Upadacitinib 7.5 mg
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.
Drug: Placebo
Tablet
Drug: Upadacitinib
Tablet for oral use
Other Names:
  • ABT-494
  • RINVOQ™
Experimental: Upadacitinib 15 mg
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.
Drug: Placebo
Tablet
Drug: Upadacitinib
Tablet for oral use
Other Names:
  • ABT-494
  • RINVOQ™
Experimental: Upadacitinib 30 mg
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.
Drug: Placebo
Tablet
Drug: Upadacitinib
Tablet for oral use
Other Names:
  • ABT-494
  • RINVOQ™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
Time Frame: Baseline and 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.
Baseline and Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75) at Week 16
Time Frame: Baseline and 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).
Baseline and Week 16
Percentage of Participants Achieving an Investigator Global Assessment (IGA) of "0" or "1" at Week 16
Time Frame: 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.
Week 16
Percent Change From Baseline to Weeks 2, 8, and 16 in Pruritus Numerical Rating Scale (NRS)
Time Frame: Baseline and Weeks 2, 8, and 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 percent change from Baseline at each week was calculated from a rolling weekly average.
Baseline and Weeks 2, 8, and 16
Percent Change From Baseline in EASI Score at Week 8
Time Frame: Baseline and 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.
Baseline and Week 8
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Weeks 8 and 16
Time Frame: Baseline and 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.
Baseline and Weeks 8 and 16
Percentage of Participants Who Achieved an EASI 75 Response at Week 8
Time Frame: Baseline and 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).
Baseline and Week 8
Percentage of Participants Who Achieved an EASI 50 Response at Weeks 8 and 16
Time Frame: Baseline and 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).
Baseline and Weeks 8 and 16
Percentage of Participants Who Achieved an EASI 90 Response at Weeks 8 and 16
Time Frame: Baseline and 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).
Baseline and Weeks 8 and 16
Percentage of Participants Who Achieved a SCORAD 50 Response at Weeks 8 and 16
Time Frame: Baseline and 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).
Baseline and Weeks 8 and 16
Percentage of Participants Who Achieved a SCORAD 75 Response at Weeks 8 and 16
Time Frame: Baseline and 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).
Baseline and Weeks 8 and 16
Percentage of Participants Who Achieved a SCORAD 90 Response at Weeks 8 and 16
Time Frame: Baseline and 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).
Baseline and Weeks 8 and 16
Percent Change From Re-randomization (Week 16) in EASI Score in Period 2
Time Frame: Re-randomization (Week 16) and Weeks 20, 24, 32, 40, 52, 64, 76, and 88

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.
Re-randomization (Week 16) and Weeks 20, 24, 32, 40, 52, 64, 76, and 88
Time to Loss of EASI 50 Response Relative to Baseline Among Participants Re-randomized as EASI 75 Responders at Week 16
Time Frame: From re-randomization at Week 16 until Week 88

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.
From re-randomization at Week 16 until Week 88
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
Time Frame: Weeks 20, 24, 32, 40, 52, 64, 76, and 88

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.
Weeks 20, 24, 32, 40, 52, 64, 76, and 88
Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) of "0" or "1" at Weeks 8 and 16
Time Frame: 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.
Weeks 8 and 16
Change From Baseline in DLQI at Weeks 8 and 16
Time Frame: Baseline and 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.
Baseline and Weeks 8 and 16
Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
Time Frame: Baseline and 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.
Baseline and Week 16
Percentage of Participants With Reduction of ≥ 4 Points From Baseline in Pruritus NRS at Week 16
Time Frame: Baseline and 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).
Baseline and Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2016

Primary Completion (Actual)

August 10, 2017

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M16-048
  • 2016-002451-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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