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A Study of Oral Upadacitinib Tablets to Assess Change in Disease State in Participants Aged 12-75 Years With Moderate to Severe Atopic Dermatitis in Brazil

Primary Purpose

Atopic Dermatitis (AD)

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Upadacitinib

Placebo for Upadacitinib

About this trial

This is an interventional treatment trial for Atopic Dermatitis (AD) focused on measuring Atopic Dermatitis, Upadacitinib, ABT-494, Rinvoq

Eligibility Criteria

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

Inclusion Criteria:

Body weight >= 40 kg at the Baseline Visit for participants between >= 12 and < 18 years of age.
Chronic Atopic Dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria.
Eczema Area and Severity Index (EASI) score >= 16 at the Screening and Baseline Visits.
Validated Investigator Global Assessment for AD (vIGA-AD) score ≥ 3 at the Screening and Baseline Visits.
>= 10% body surface area of AD involvement at the Screening and Baseline Visits.
Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 at Screening and Baseline Visits.
Documented history (within 1 year prior to the Screening Visit) of inadequate response (IR) to systemic methotrexate (MTX) and/or cyclosporin A (CsA) or not a candidate for systemic treatment with MTX or CsA as a result of intolerance or medical contraindication.

Exclusion Criteria:

Prior exposure to any systemic Janus kinase (JAK) inhibitor.
Prior exposure to dupilumab.
Must not have used the following AD treatments within the specified timeframe prior to Baseline Visit:
- Corticosteroids, MTX, CsA, azathioprine. phosphodiesterase type 4 (PDE4)-inhibitors, interferon-γ, and mycophenolate mofetil within 4 weeks.
- Targeted biologic treatments (refer to within 5 half-lives [if known]) or within 12 weeks, whichever is longer.
- Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.
- Oral or parenteral traditional medicine within 4 weeks.
- Moisturizers that contain Topical corticosteroids (TCS), Topical calcineurin inhibitor (TCI)s, or topical Phosphodiesterase type 4 (PDE-4) inhibitors within 7 days.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Upadacitinib Dose A

Upadacitinib Dose B

Placebo for Upadacitinib Followed by Upadacitinib Dose A

Placebo for Upadacitinib Followed by Upadacitinib Dose B

Arm Description

Participants will receive Upadacitinib Dose A once daily (QD).

Participants will receive Upadacitinib Dose B QD.

Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose A QD.

Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose B QD.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving at least a 75% Reduction in Eczema Area and Severity Index (EASI 75) from Baseline

The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).

Number of Participants With Adverse Events (AE)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Secondary Outcome Measures

Percentage of Participants Achieving at least a 90% Reduction in Eczema Area and Severity Index (EASI 90) from Baseline

The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.

Full Information

NCT ID

NCT04666675

First Posted

December 8, 2020

Last Updated

April 7, 2021

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT04666675

Brief Title

A Study of Oral Upadacitinib Tablets to Assess Change in Disease State in Participants Aged 12-75 Years With Moderate to Severe Atopic Dermatitis in Brazil

Official Title

A Phase 3b Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis in Brazil

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Strategic considerations

Study Start Date

December 24, 2020 (Anticipated)

Primary Completion Date

March 23, 2021 (Actual)

Study Completion Date

March 23, 2021 (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.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Atopic Dermatitis (AD) is a chronic inflammatory skin disease that is characterized by intense itching, oozing and crusting, redness, skin erosion and dry skin. This study will evaluate how well upadacitinib compared to placebo (no medicine) works to treat participants with moderate to severe AD in Brazil. The study will assess change in disease signs and symptoms. Upadacitinib is an investigational drug being developed for the treatment of Atopic Dermatitis (AD). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Participants with a diagnosis of AD will be enrolled. Around 150 participants will be enrolled in the study in approximately 20 sites in Brazil. Participants will receive the following for up to 52 weeks: Participants will receive oral upadacitinib tablets once daily for up to week 52. Participants may also receive oral placebo tablets once daily up to week 16 followed by oral upadacitinib tablets once daily up to week 52. Arm 1: Upadacitinib Dose A up to week 52. Arm 2: Upadacitinib Dose B up to week 52. Arm 3: Placebo up to week 16 followed by upadacitinib Dose A up to week 52. Arm 4: Placebo up to week 16 followed by upadacitinib Dose B up to week 52. There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

6. Conditions and Keywords

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

Atopic Dermatitis (AD)

Keywords

Atopic Dermatitis, Upadacitinib, ABT-494, Rinvoq

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Upadacitinib Dose A

Arm Type

Experimental

Arm Description

Participants will receive Upadacitinib Dose A once daily (QD).

Arm Title

Upadacitinib Dose B

Arm Type

Experimental

Arm Description

Participants will receive Upadacitinib Dose B QD.

Arm Title

Placebo for Upadacitinib Followed by Upadacitinib Dose A

Arm Type

Experimental

Arm Description

Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose A QD.

Arm Title

Placebo for Upadacitinib Followed by Upadacitinib Dose B

Arm Type

Experimental

Arm Description

Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose B QD.

Intervention Type

Drug

Intervention Name(s)

Upadacitinib

Other Intervention Name(s)

Rinvoq, ABT-494

Intervention Description

Oral; Tablet

Intervention Type

Drug

Intervention Name(s)

Placebo for Upadacitinib

Intervention Description

Oral; Tablet

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving at least a 75% Reduction in Eczema Area and Severity Index (EASI 75) from Baseline

Description

The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).

Time Frame

Baseline to Week 16

Title

Number of Participants With Adverse Events (AE)

Description

Time Frame

Up to Week 52

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving at least a 90% Reduction in Eczema Area and Severity Index (EASI 90) from Baseline

Description

The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.

Time Frame

Baseline to Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Body weight >= 40 kg at the Baseline Visit for participants between >= 12 and < 18 years of age. Chronic Atopic Dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria. Eczema Area and Severity Index (EASI) score >= 16 at the Screening and Baseline Visits. Validated Investigator Global Assessment for AD (vIGA-AD) score ≥ 3 at the Screening and Baseline Visits. >= 10% body surface area of AD involvement at the Screening and Baseline Visits. Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 at Screening and Baseline Visits. Documented history (within 1 year prior to the Screening Visit) of inadequate response (IR) to systemic methotrexate (MTX) and/or cyclosporin A (CsA) or not a candidate for systemic treatment with MTX or CsA as a result of intolerance or medical contraindication. Exclusion Criteria: Prior exposure to any systemic Janus kinase (JAK) inhibitor. Prior exposure to dupilumab. Must not have used the following AD treatments within the specified timeframe prior to Baseline Visit: Corticosteroids, MTX, CsA, azathioprine. phosphodiesterase type 4 (PDE4)-inhibitors, interferon-γ, and mycophenolate mofetil within 4 weeks. Targeted biologic treatments (refer to within 5 half-lives [if known]) or within 12 weeks, whichever is longer. Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks. Oral or parenteral traditional medicine within 4 weeks. Moisturizers that contain Topical corticosteroids (TCS), Topical calcineurin inhibitor (TCI)s, or topical Phosphodiesterase type 4 (PDE-4) inhibitors within 7 days.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

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

Links:

URL

https://www.rxabbvie.com

Description

This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Learn more about this trial

A Study of Oral Upadacitinib Tablets to Assess Change in Disease State in Participants Aged 12-75 Years With Moderate to Severe Atopic Dermatitis in Brazil

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