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

NCT02925117 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: M16-0482016-002451-21
• Study Type: interventional
• Target: 167
• Locations: 8 countries
• Sites: 34

Brief Summary

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).

Conditions

Atopic Dermatitis

Keywords

ABT-494; Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at 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 Outcomes (18)

• Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75) at Week 16

  Baseline and Week 16

• Percentage of Participants Achieving an Investigator Global Assessment (IGA) of "0" or "1" at Week 16

  Week 16

• Percent Change From Baseline to Weeks 2, 8, and 16 in Pruritus Numerical Rating Scale (NRS)

  Baseline and Weeks 2, 8, and 16

• Percent Change From Baseline in EASI Score at Week 8

  Baseline and Week 8

• Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Weeks 8 and 16

  Baseline and Weeks 8 and 16

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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: Upadacitinib; Drug: Placebo

Upadacitinib 7.5 mg

EXPERIMENTAL

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: Upadacitinib; Drug: Placebo

Upadacitinib 15 mg

EXPERIMENTAL

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: Upadacitinib; Drug: Placebo

Upadacitinib 30 mg

EXPERIMENTAL

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: Upadacitinib; Drug: Placebo

Interventions

Upadacitinib DRUG

Tablet for oral use

Also known as: RINVOQ™, ABT-494

Placebo; Upadacitinib 15 mg; Upadacitinib 30 mg; Upadacitinib 7.5 mg

Placebo DRUG

Tablet

Placebo; Upadacitinib 15 mg; Upadacitinib 30 mg; Upadacitinib 7.5 mg

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (34)

ForCare Clinical Research /ID# 157974

Tampa, Florida, 33613-1244, United States

Location

Advanced Medical Research /ID# 154516

Sandy Springs, Georgia, 30328-6141, United States

Location

DermAssociates /ID# 153584

Rockville, Maryland, 20850, United States

Location

Tufts Medical Center /ID# 153586

Boston, Massachusetts, 02111, United States

Location

Psoriasis Treatment Ctr NJ /ID# 153578

East Windsor, New Jersey, 08520, United States

Location

Icahn School of Med Mt. Sinai /ID# 153582

New York, New York, 10029, United States

Location

Univ Rochester Med Ctr /ID# 154477

Rochester, New York, 14642, United States

Location

Arlington Research Center, Inc /ID# 154522

Arlington, Texas, 76011, United States

Location

Modern Research Associates, PL /ID# 154487

Dallas, Texas, 75231, United States

Location

Center for Clinical Studies /ID# 153589

Houston, Texas, 77004, United States

Location

Woden Dermatology /ID# 157907

Phillip, Australian Capital Territory, 2606, Australia

Location

St George Hospital /ID# 157908

Kogarah, New South Wales, 2217, Australia

Location

Specialist Connect Pty Ltd /ID# 157909

Woolloongabba, Queensland, 4102, Australia

Location

Skin Health Institute Inc /ID# 157906

Carlton, Victoria, 3053, Australia

Location

Institute for Skin Advancement /ID# 153246

Calgary, Alberta, T3A 2N1, Canada

Location

Dr. Chih-ho Hong Medical Inc. /ID# 153241

Surrey, British Columbia, V3R 6A7, Canada

Location

Enverus Medical Research /ID# 153239

Surrey, British Columbia, V3V 0C6, Canada

Location

CCA Medical Research /ID# 155817

Ajax, Ontario, L1S 7K8, Canada

Location

Lynderm Research Inc. /ID# 153242

Markham, Ontario, L3P 1X2, Canada

Location

Dermatology Ottawa Research Centre /ID# 153248

Ottawa, Ontario, K2C 3N2, Canada

Location

K. Papp Clinical Research /ID# 153244

Waterloo, Ontario, N2J 1C4, Canada

Location

Mehiläinen Neo /ID# 154960

Turku, Southwest Finland, 20520, Finland

Location

Mikkeli Central Hospital /ID# 154959

Mikkeli, 50100, Finland

Location

TFS Trial Form Support GmbH /ID# 155442

Hamburg, 20354, Germany

Location

Fukuoka University Hospital /ID# 152714

Fukuoka, Fukuoka, 814-0180, Japan

Location

Takagi Dermatological Clinic /ID# 152706

Obihiro-shi, Hokkaido, 080-0013, Japan

Location

Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 153781

Sapporo, Hokkaido, 060-0063, Japan

Location

Nippon Medical School Hospital /ID# 153287

Tokyo, 113-8602, Japan

Location

Radboud Universitair Medisch Centrum /ID# 153688

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Academisch Medisch Centrum /ID# 153596

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Universitair Medisch Centrum Groningen /ID# 153595

Groningen, 9713 GZ, Netherlands

Location

Universitair Medisch Centrum Utrecht /ID# 153687

Utrecht, 3584 CX, Netherlands

Location

Hospital Santa Creu i Sant Pau /ID# 153519

Barcelona, 08026, Spain

Location

Hospital Univ Germans Trias I /ID# 155598

Barcelona, 08916, Spain

Location

Related Publications (1)

• Guttman-Yassky E, Thaci D, Pangan AL, Hong HC, Papp KA, Reich K, Beck LA, Mohamed MF, Othman AA, Anderson JK, Gu Y, Teixeira HD, Silverberg JI. Upadacitinib in adults with moderate to severe atopic dermatitis: 16-week results from a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2020 Mar;145(3):877-884. doi: 10.1016/j.jaci.2019.11.025. Epub 2019 Nov 29.

  PMID: 31786154 RESULT

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

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: October 4, 2016
• First Posted: October 5, 2016
• Study Start: October 25, 2016
• Primary Completion: August 10, 2017
• Study Completion: January 31, 2019
• Last Updated: July 16, 2020
• Results First Posted: July 16, 2020

Record last verified: 2020-07

Data Sharing

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

Locations

US (10); ES (2); FI (2); CA (7); DE (1); JP (4); NL (4); AU (4)