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

NCT ID: NCT04927975

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2023-08-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Oral tablets

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

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.

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Oral tablets

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

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.

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Oral tablets

Placebo Period 1, then Upa 22 mg Period 2

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.

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Oral tablets

Placebo

Intervention Type: DRUG

Oral tablets

Placebo Period 1, then Upa 11 mg Period 2

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.

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Oral tablets

Placebo

Intervention Type: DRUG

Oral tablets

Interventions

Upadacitinib

Oral tablets

Intervention Type: DRUG

Placebo

Oral tablets

Intervention Type: DRUG

Other Intervention Names

ABT-494; RINVOQ

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

University of California Irvine /ID# 229390

Irvine, California, United States

Stanford University /ID# 228000

Redwood City, California, United States

Clearlyderm Dermatology /ID# 227993

Boca Raton, Florida, United States

New Horizon Research Center /ID# 229403

Miami, Florida, United States

Park Avenue Dermatology, PA /ID# 229400

Orange Park, Florida, United States

ForCare Clinical Research /ID# 228010

Tampa, Florida, United States

Dawes Fretzin, LLC /ID# 227996

Indianapolis, Indiana, United States

Tufts Medical Center /ID# 228087

Boston, Massachusetts, United States

Duplicate_UMass Chan Medical School /ID# 228066

Worcester, Massachusetts, United States

Duplicate_Michigan Center for Research Company /ID# 228054

Clarkston, Michigan, United States

Hamzavi Dermatology /ID# 228056

Fort Gratiot, Michigan, United States

Remington-Davis Clinical Research /ID# 229401

Columbus, Ohio, United States

Essential Medical Research, LLC /ID# 228074

Tulsa, Oklahoma, United States

Oregon Dermatology and Research Center /ID# 228007

Portland, Oregon, United States

Oregon Medical Research Center /ID# 228073

Portland, Oregon, United States

Duplicate_Medical University of South Carolina /ID# 228067

Charleston, South Carolina, United States

International Clinical Research - Tennessee LLC /ID# 228059

Murfreesboro, Tennessee, United States

Bellaire Dermatology Associates /ID# 228004

Bellaire, Texas, United States

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

Houston, Texas, United States

Virginia Clinical Research, Inc. /ID# 228050

Norfolk, Virginia, United States

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

Surrey, British Columbia, Canada

Wiseman Dermatology Research /ID# 228410

Winnipeg, Manitoba, Canada

Research Toronto /ID# 228401

Toronto, Ontario, Canada

Duplicate_K. Papp Clinical Research /ID# 228877

Waterloo, Ontario, Canada

Centre de Recherche dermatologique du Quebec Metropolitain /ID# 228388

Québec, Quebec, Canada

Chu de Nice-Hopital Larchet Ii /Id# 228192

Nice, Alpes-Maritimes, France

Duplicate_Hopital Saint-Andre /ID# 228193

Bordeaux, Gironde, France

HCL - Hopital Edouard Herriot /ID# 228194

Lyon, Rhone, France

Duplicate_Hopital Henri Mondor /ID# 228198

Créteil, , France

CHU Toulouse - Hopital Larrey /ID# 228196

Toulouse, , France

Nagoya City University Hospital /ID# 228725

Nagoya, Aichi-ken, Japan

Nippon Medical School Hospital /ID# 230361

Bunkyo-ku, Tokyo, Japan

Tokyo Medical University Hospital /ID# 230288

Shinjuku-ku, Tokyo, Japan

Yamagata University Hospital /ID# 230362

Yamagata, Yamagata, Japan

Yamanashi Prefectural Central Hospital /ID# 229441

Kofu, Yamanashi, Japan

Countries

United States; Canada; France; Japan

References

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.

Reference Type: DERIVED

PMID: 39475960 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38873632 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.rxabbvie.com/

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

Other Identifiers

2021-000081-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M19-051

Identifier Type: -

Identifier Source: org_study_id