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A Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03706040
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adult and adolescent subjects.

Condition or disease Intervention/treatment Phase
Dermatitis Biological: placebo for rizankizumab Biological: risankizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : November 12, 2020
Estimated Study Completion Date : April 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants randomized to receive double-blind (DB) placebo for 16 weeks (Period A) followed by either DB risankizumab Dose 1 or DB risankizumab Dose 2 for 24 weeks (Period B).
Biological: placebo for rizankizumab
subcutaneous (SC) injection

Experimental: Risankizumab Dose 1
Participants randomized to receive double-blind (DB) risankizumab Dose 1 for 16 weeks (Period A) followed by DB risankizumab Dose 1 for 24 weeks (Period B).
Biological: risankizumab
subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Risankizumab Dose 2
Participants randomized to receive double-blind (DB) risankizumab Dose 2 for 16 weeks (Period A) followed by DB risankizumab Dose 2 for 24 weeks (Period B).
Biological: risankizumab
subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066




Primary Outcome Measures :
  1. Percentage of Participants Achieving At Least a 75% Reduction from Baseline in Eczema Area and Severity Index (EASI 75) [ Time Frame: Week 16 ]
    The EASI is a tool used to measure the area and severity of atopic eczema.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Score of "0" Or "1" With a Reduction From Baseline of ≥ 2 Points [ Time Frame: Week 16 ]
    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of atopic dermatitis globally.

  2. Percentage of Participants Achieving a Reduction of ≥ 4 Points in Worst Pruritus Numerical Rating Scale (NRS) from Baseline [ Time Frame: Baseline, Week 16 ]
    The Worst Pruritis NRS asks the participant to rate itch (pruritis) intensity at its worst during the past 24 hours.



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

Inclusion Criteria:

  • adults who are ≥ 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old
  • a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria
  • moderate to severe AD at the Baseline Visit
  • history of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments

Exclusion Criteria:

  • prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor
  • concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments

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): NCT03706040


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

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

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03706040     History of Changes
Other Study ID Numbers: M16-813
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
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

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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
Atopic dermatitis (atopic eczema)
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs