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

NCT04666675 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: M20-412
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atopic Dermatitis (AD)

Keywords

Atopic Dermatitis; Upadacitinib; ABT-494; Rinvoq

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline to Week 16

• 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.

  Up to Week 52

Secondary Outcomes (1)

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

  Baseline to Week 16

Study Arms (4)

Upadacitinib Dose A

EXPERIMENTAL

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

Drug: Upadacitinib

Upadacitinib Dose B

EXPERIMENTAL

Participants will receive Upadacitinib Dose B QD.

Drug: Upadacitinib

Placebo for Upadacitinib Followed by Upadacitinib Dose A

EXPERIMENTAL

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

Drug: Upadacitinib; Drug: Placebo for Upadacitinib

Placebo for Upadacitinib Followed by Upadacitinib Dose B

EXPERIMENTAL

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

Drug: Upadacitinib; Drug: Placebo for Upadacitinib

Interventions

Upadacitinib DRUG

Oral; Tablet

Also known as: Rinvoq, ABT-494

Placebo for Upadacitinib Followed by Upadacitinib Dose A; Placebo for Upadacitinib Followed by Upadacitinib Dose B; Upadacitinib Dose A; Upadacitinib Dose B

Placebo for Upadacitinib DRUG

Oral; Tablet

Placebo for Upadacitinib Followed by Upadacitinib Dose A; Placebo for Upadacitinib Followed by Upadacitinib Dose B

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 14, 2020
• Study Start: December 24, 2020
• Primary Completion: March 23, 2021
• Study Completion: March 23, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.