A study to assess adverse events and effectiveness of upadacitinib oral tablets in adult and adolescent participants with vitiligo.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

5 Apr 2024 → ongoing

Decision date (initial)

2024-03-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-506195-27-00

ClinicalTrials.gov

NCT06118411

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy

The primary objective of Study 1 and Study 2 is to evaluate the efficacy, safety, and tolerability of upadacitinib for the treatment of adults and adolescents with NSV who are eligible for systemic therapy.

Secondary objectives 3

1. The proportion of subjects achieving each of the ranked secondary binary endpoints in those treated with upadacitinib 15 mg is greater than those treated with placebo.
2. Percent change from Baseline in F-VASI in those treated with upadacitinib 15 mg is greater than those treated with placebo at Week 24.
3. Percent change from Baseline in T-VASI in those treated with upadacitinib 15 mg is greater than those treated with placebo at Week 48.

Conditions and MedDRA coding

non-segmental vitiligo

Regulatory references

Scientific advice from competent authorities

AbbVie Deutschland GmbH & Co. KG

EMA paediatric investigation plan (PIP)

EMEA-001741-PIP07-22

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Subjects or their legally authorized representative (if required per local regulations) must be able to understand and be willing to adhere to all protocol requirements and voluntarily sign and date an informed consent (and assent for minors as required by applicable regulation), approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures.
2. Adult and adolescent individuals, ≥ 12 years of age at Screening.
3. Body weight must be ≥ 30 kg at Baseline Visit for subjects who are ≥ 12 and < 18 years of age.
4. Documented clinical diagnosis of NSV.
5. At Screening and Baseline Visits, subject must satisfy at least 1 of the following criteria: · ≥ 0.5 F-VASI and 5 ≤ T-VASI < 50 AND have failed at least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for vitiligo; or · ≥ 0.5 F-VASI and 5 ≤ T-VASI < 50 AND have a sign of actively progressing vitiligo; or · ≥ 0.5 F-VASI and 10 ≤ T-VASI < 50.
6. Subject is judged to be in good health as determined by the Principal Investigator, based upon the results of the Screening assessments and medical history.
7. Pregnancy testing in female subjects of childbearing potential • Females of childbearing potential must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at Baseline prior to the first dose of study drug (local practices may require serum pregnancy testing at Baseline). • Subjects with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result (unless prohibited by local requirements). • Subjects with a urine pregnancy test at Baseline that is borderline or ambiguous must have a serum pregnancy test

Exclusion criteria 10

1. Subject has segmental or localized vitiligo.
2. Subject has a history of active skin disease other than vitiligo that could interfere with the assessment of vitiligo.
3. Subject must not have > 33% leukotrichia in areas of vitiligo on the face or > 33% leukotrichia in areas of vitiligo on the body (including the face).
4. Subject has current or past history of any of the following infections: •Two or more episodes of herpes zoster, or one or more episodes or disseminated herpes zoster; • One or more episodes of disseminated herpes simplex (including eczema herpeticum); • Human immunodeficiency virus infection defined as confirmed positive anti-HIV antibody test; • Active TB or meet TB exclusionary parameters (specific requirements for TB testing will be provided in the Operations Manual [Appendix F]);
5. Subject has evidence of: • HBV • HCV
6. There must be no reason the investigator believes that the subject is an unsuitable candidate to participate in the study, receive study drug, or would be placed at risk by participating in the study.
7. Subject must not have a history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
8. The investigator believes that the subject is an unsuitable candidate to participate in the study, receive study drug, or would be placed at risk by participating in the study.
9. Subject has been treated with any systemic JAK inhibitor.
10. Subject has been treated with any permanent skin bleaching agents.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Achievement of T-VASI 50 (≥ 50% reduction in T-VASI from Baseline) at Week 48
2. Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 48

Secondary endpoints 8

1. Achievement of F-VASI 50 (≥ 50% reduction in F-VASI from Baseline) at Week 48;
2. Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 24;
3. Percent change from Baseline in F-VASI at Week 24;
4. Percent change from Baseline in T-VASI at Week 48;
5. Achievement of F-VASI 90 (≥ 90% reduction in F-VASI from Baseline) at Week 48;
6. Achievement of VNS score of "A lot less noticeable (4)" or "No longer noticeable (5)" at Week 48;
7. Achievement of PaGIC-V of "Much better (1)" at Week 48.
8. Achievement of PhGIC-V of "Much better (1)" at Week 48;

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 5

Locations

11 EU/EEA countries · 58 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 172 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

12 submissions — initial application plus substantial / non-substantial modifications