Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo

NCT04927975 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: M19-0512021-000081-15
• Study Type: interventional
• Target: 185
• Locations: 4 countries
• Sites: 35

Brief Summary

Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo. Adverse effects and change in disease activity will be assessed. Upadacitinib is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 160 participants aged 18-65 with non-segmental vitiligo in 5 treatment arms across 35 sites worldwide. Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions

Non-Segmental Vitiligo

Keywords

Vitiligo; Non-segmental vitiligo (NSV); Upadacitinib; ABT-494; RINVOQ

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24

  The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement.

  Baseline, Week 24

Secondary Outcomes (5)

• Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) at Week 24

  Baseline, Week 24

• Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline) at Week 24

  Baseline, Week 24

• Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline) at Week 24

  Baseline, Week 24

• Percent Change From Baseline in T-VASI at Week 24

  Baseline, Week 24

• Change From Baseline in the Vitiligo Quality-of-Life (VitiQoL) Instrument Total Score at Week 24

  Baseline, Week 24

Study Arms (5)

Upa 22 mg Period 1, then Upa 22 mg Period 2

EXPERIMENTAL

Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.

Drug: Upadacitinib

Upa 11 mg Period 1, then Upa 11 mg Period 2

EXPERIMENTAL

Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.

Drug: Upadacitinib

Upa 6 mg Period 1, then Upa 6 mg Period 2

EXPERIMENTAL

Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.

Drug: Upadacitinib

Placebo Period 1, then Upa 22 mg Period 2

EXPERIMENTAL

Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.

Drug: Upadacitinib; Drug: Placebo

Placebo Period 1, then Upa 11 mg Period 2

EXPERIMENTAL

Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.

Drug: Upadacitinib; Drug: Placebo

Interventions

Upadacitinib DRUG

Oral tablets

Also known as: ABT-494, RINVOQ

Placebo Period 1, then Upa 11 mg Period 2; Placebo Period 1, then Upa 22 mg Period 2; Upa 11 mg Period 1, then Upa 11 mg Period 2; Upa 22 mg Period 1, then Upa 22 mg Period 2; Upa 6 mg Period 1, then Upa 6 mg Period 2

Placebo DRUG

Oral tablets

Placebo Period 1, then Upa 11 mg Period 2; Placebo Period 1, then Upa 22 mg Period 2

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of non-segmental vitiligo (NSV) and no segmental or localized vitiligo.
• Participants with all of the following at Screening and Baseline.
• Visits: ≥ 0.5 F-VASI and ≥ 5 total vitiligo area scoring index (T-VASI).
• Participants who have had prior exposure to immunomodulatory biologic therapy, for any indications, but discontinued the biologic therapy prior to the first dose of study drug. Recommended washout periods for biologic therapies include ≥ 4 weeks for etanercept; ≥ 8 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and ixekizumab; ≥ 16 weeks for secukinumab; and ≥ 12 weeks for ustekinumab. For biologic therapies not specified, therapies must be discontinued at least 5 times the mean terminal elimination half-life of a drug or 3 months prior to Baseline, whichever is longer.

You may not qualify if:

• Participants with segmental or localized vitiligo.
• Participants with other skin conditions that would interfere with evaluation of vitiligo, participants with uncontrolled thyroid disease, and participants with \> 33% leukotrichia on the face or \> 33% leukotrichia on the body (including face).
• Participants previously treated with any topical or systemic janus kinase (JAK) inhibitor or permanent skin bleaching agents.
• Participants treated with any systemic vitiligo therapy (e.g., methotrexate, mycophenolate mofetil, corticosteroids), supplemental vitiligo therapy (antioxidants/vitamins/herbal medicine/traditional Chinese medicine), and/or topical vitiligo therapy including permanent or temporary tattoos within a minimum of 30 days prior to the first dose of study drug (Note: Camouflage and makeup may be used).
• Participants treated with any phototherapy, including excimer (or other forms of laser therapy), within a minimum of 12 weeks prior to the first dose of study drug.
• Participants have history of malignancy other than successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
• Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery;
• History of an organ transplant which requires continued immunosuppression;
• History of gastrointestinal (GI) perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;
• Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded;
• Uncontrolled thyroid disease;

Sponsors & Collaborators

• AbbVie: lead

Study Sites (35)

University of California Irvine /ID# 229390

Irvine, California, 92697-1385, United States

Location

Stanford University /ID# 228000

Redwood City, California, 94063, United States

Location

Clearlyderm Dermatology /ID# 227993

Boca Raton, Florida, 33428, United States

Location

New Horizon Research Center /ID# 229403

Miami, Florida, 33165-3372, United States

Location

Park Avenue Dermatology, PA /ID# 229400

Orange Park, Florida, 32073, United States

Location

ForCare Clinical Research /ID# 228010

Tampa, Florida, 33613-1244, United States

Location

Dawes Fretzin, LLC /ID# 227996

Indianapolis, Indiana, 46256, United States

Location

Tufts Medical Center /ID# 228087

Boston, Massachusetts, 02111-1552, United States

Location

Duplicate_UMass Chan Medical School /ID# 228066

Worcester, Massachusetts, 01655, United States

Location

Duplicate_Michigan Center for Research Company /ID# 228054

Clarkston, Michigan, 48346, United States

Location

Hamzavi Dermatology /ID# 228056

Fort Gratiot, Michigan, 48059, United States

Location

Remington-Davis Clinical Research /ID# 229401

Columbus, Ohio, 43215, United States

Location

Essential Medical Research, LLC /ID# 228074

Tulsa, Oklahoma, 74137-2842, United States

Location

Oregon Dermatology and Research Center /ID# 228007

Portland, Oregon, 97210, United States

Location

Oregon Medical Research Center /ID# 228073

Portland, Oregon, 97223, United States

Location

Duplicate_Medical University of South Carolina /ID# 228067

Charleston, South Carolina, 29425, United States

Location

International Clinical Research - Tennessee LLC /ID# 228059

Murfreesboro, Tennessee, 37130-2450, United States

Location

Bellaire Dermatology Associates /ID# 228004

Bellaire, Texas, 77401, United States

Location

University of Texas Health Science Center at Houston /ID# 229399

Houston, Texas, 77030-1501, United States

Location

Virginia Clinical Research, Inc. /ID# 228050

Norfolk, Virginia, 23502, United States

Location

Dr. Chih-ho Hong Medical Inc. /ID# 228403

Surrey, British Columbia, V3R 6A7, Canada

Location

Wiseman Dermatology Research /ID# 228410

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Research Toronto /ID# 228401

Toronto, Ontario, M4W 2N4, Canada

Location

Duplicate_K. Papp Clinical Research /ID# 228877

Waterloo, Ontario, N2J 1C4, Canada

Location

Centre de Recherche dermatologique du Quebec Metropolitain /ID# 228388

Québec, Quebec, G1V 4X7, Canada

Location

Chu de Nice-Hopital Larchet Ii /Id# 228192

Nice, Alpes-Maritimes, 06200, France

Location

Duplicate_Hopital Saint-Andre /ID# 228193

Bordeaux, Gironde, 33075, France

Location

HCL - Hopital Edouard Herriot /ID# 228194

Lyon, Rhone, 69003, France

Location

Duplicate_Hopital Henri Mondor /ID# 228198

Créteil, 94000, France

Location

CHU Toulouse - Hopital Larrey /ID# 228196

Toulouse, 31400, France

Location

Nagoya City University Hospital /ID# 228725

Nagoya, Aichi-ken, 467-8602, Japan

Location

Nippon Medical School Hospital /ID# 230361

Bunkyo-ku, Tokyo, 113-8602, Japan

Location

Tokyo Medical University Hospital /ID# 230288

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Yamagata University Hospital /ID# 230362

Yamagata, Yamagata, 990-9585, Japan

Location

Yamanashi Prefectural Central Hospital /ID# 229441

Kofu, Yamanashi, 400-8506, Japan

Location

Related Publications (2)

• Ezzedine K, Soliman AM, Camp HS, Ladd MK, Pokrzywinski R, Coyne KS, Sen R, Schlosser BJ, Bae JM, Hamzavi I. Psychometric Properties and Meaningful Change Thresholds of the Vitiligo Area Scoring Index. JAMA Dermatol. 2025 Jan 1;161(1):39-46. doi: 10.1001/jamadermatol.2024.4534.

  PMID: 39475960 DERIVED

• Passeron T, Ezzedine K, Hamzavi I, van Geel N, Schlosser BJ, Wu X, Huang X, Soliman AM, Rosmarin D, Harris JE, Camp HS, Pandya AG. Once-daily upadacitinib versus placebo in adults with extensive non-segmental vitiligo: a phase 2, multicentre, randomised, double-blind, placebo-controlled, dose-ranging study. EClinicalMedicine. 2024 May 31;73:102655. doi: 10.1016/j.eclinm.2024.102655. eCollection 2024 Jul.

  PMID: 38873632 DERIVED

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

Vitiligo

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue 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: June 11, 2021
• First Posted: June 16, 2021
• Study Start: June 30, 2021
• Primary Completion: January 13, 2023
• Study Completion: August 29, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• 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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

FR (5); JP (5); US (20); CA (5)