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Trial record 19 of 159 for:    Recruiting, Not yet recruiting, Available Studies | "Eczema"

Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1 (Measure Up 1)

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ClinicalTrials.gov Identifier: NCT03569293
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe Atopic Dermatitis (AD) who are candidates for systemic therapy.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Upadacitinib Drug: Placebo for Upadacitinib Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : May 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Arm A
Upadacitinib Dose A is administered once daily.
Drug: Upadacitinib
It is administered orally.
Other Name: ABT-494

Experimental: Arm B
Upadacitinib Dose B is administered once daily.
Drug: Upadacitinib
It is administered orally.
Other Name: ABT-494

Experimental: Arm C
Placebo administered once daily followed by Upadacitinib Dose A once daily.
Drug: Upadacitinib
It is administered orally.
Other Name: ABT-494

Drug: Placebo for Upadacitinib
It is administered orally.

Experimental: Arm D
Placebo administered once daily followed by Upadacitinib Dose B once daily.
Drug: Upadacitinib
It is administered orally.
Other Name: ABT-494

Drug: Placebo for Upadacitinib
It is administered orally.




Primary Outcome Measures :
  1. Proportion of participants achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) [ Time Frame: At Week 16 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).

  2. Proportion of participants achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction [ Time Frame: At Week 16 ]
    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally.


Secondary Outcome Measures :
  1. Proportion of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 [ Time Frame: At Week 16 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.

  2. Proportion of participants achieving EASI 90 [ Time Frame: At Week 16 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.

  3. Proportion of participants achieving EASI 50 [ Time Frame: At Week 1 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.

  4. Proportion of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 for participants randomized to dose A [ Time Frame: At Day 2 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.

  5. Proportion of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 for participants randomized to dose B [ Time Frame: At Day 3 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period.

  6. Proportion of participants achieving an improvement (reduction) in Atopic dermatitis impact scale (ADerm-IS) sleep domain score ≥ Minimal clinically important difference (MCID) [ Time Frame: At Week 16 ]
    This is assessed for participants with ADerm-IS sleep domain score ≥ MCID.

  7. Proportion of participants achieving an improvement (reduction) in Atopic dermatitis symptom scale (ADerm-SS) skin pain score ≥ Minimal clinically important difference (MCID) [ Time Frame: At Week 16 ]
    This is assessed for participants with ADerm-SS skin pain score ≥ MCID.

  8. Proportion of participants achieving an improvement (reduction) in Atopic dermatitis symptom scale (ADerm-SS) total score ≥ Minimal clinically important difference (MCID) [ Time Frame: Up to Week 16 ]
    This is assessed for participants with ADerm-SS total score ≥ MCID.

  9. Proportion of participants achieving an improvement (reduction) in ADerm-IS total score ≥ Minimal clinically important difference (MCID) [ Time Frame: Up to Week 16 ]
    This is assessed for participants with ADerm-IS total score ≥ MCID.

  10. Proportion of participants achieving EASI 100 [ Time Frame: At Week 16 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.

  11. Proportion of participants achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 with a reduction of ≥ 2 points [ Time Frame: At Week 16 ]
    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally.



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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus
  • Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis.

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor
  • Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study
  • Requirement of prohibited medications during the study
  • Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
  • Female subject who is pregnant, breastfeeding, or considering pregnancy during the 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): NCT03569293


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03569293     History of Changes
Other Study ID Numbers: M16-045
2017-005125-20 ( EudraCT Number )
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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:
Atopic Dermatitis
Upadacitinib

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