Evaluation of AMG 714 for Vitiligo

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-11

Study Completion Date

2025-04-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to evaluate the efficacy of AMG 714 for the treatment of adult participants with vitiligo.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial of SHR0302 Tablets and SHR0302 Base Gel in Patients With Non-segmental Vitiligo

NCT07251595

Non-segmental Vitiligo

RECRUITING PHASE2

Platelet-rich Plasma Intradermal Injection Combined With 308 nm Excimer Light for Treating Stable Acral Vitiligo

NCT06394349

Vitiligo

RECRUITING NA

A Trial of SHR0302Base in Patients With Vitiligo

NCT06790862

Vitiligo

ACTIVE_NOT_RECRUITING PHASE2

A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo

NCT05247489

Vitiligo

COMPLETED PHASE2

Assess the Efficacy and Safety of SHR0302 Ointment in Adult Patients With Vitiligo

NCT04774809

Vitiligo

TERMINATED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective of this trial is to determine the efficacy of interleukin-15 (IL-15) inhibition with AMG 714 at inducing facial repigmentation in vitiligo.

The secondary objectives are to:

* Evaluate the safety and tolerability of AMG 714 in vitiligo
* Determine the efficacy of IL-15 inhibition with AMG 714 at inducing total body skin repigmentation in vitiligo
* Assess the durability of the skin repigmentation achieved by AMG 714 in vitiligo
* Evaluate the efficacy of AMG 714 followed by narrow band UVB (nbUVB) phototherapy

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitiligo

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 2a, double blind, placebo-controlled, multi-center, proof of concept trial of AMG 714 for the treatment of vitiligo. Participants will be randomized 2:1 to receive AMG 714 or placebo for AMG 714. Random assignment will be stratified by active versus stable vitiligo.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AMG 714

Participants will be administered 300 mg AMG 714 beginning at Week 0 and every 2 weeks thereafter through Week 10 (for a total of 6 doses). Each dose will be administered as 2 subcutaneous injections (1.5 mL each).

Group Type EXPERIMENTAL

AMG 714

Intervention Type BIOLOGICAL

anti-IL-15 monoclonal antibody (Anti-IL-15 MAB)

nbUVB phototherapy

Intervention Type PROCEDURE

Participants will undergo narrow band ultraviolet B (nbUVB) phototherapy if their total body Vitiligo Area Scoring Index (T-VASI) does not improve by ≥ 25% at Week 24 compared to Week 0. Phototherapy will be administered in accordance with the Vitiligo Working Group expert recommendations.

Placebo

Participants will be administered placebo as 2 subcutaneous injections (1.5 mL each) beginning at Week 0 and every 2 weeks thereafter through Week 10 (for a total of 6 doses).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo for AMG 714

nbUVB phototherapy

Intervention Type PROCEDURE

Participants will undergo narrow band ultraviolet B (nbUVB) phototherapy if their total body Vitiligo Area Scoring Index (T-VASI) does not improve by ≥ 25% at Week 24 compared to Week 0. Phototherapy will be administered in accordance with the Vitiligo Working Group expert recommendations.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AMG 714

anti-IL-15 monoclonal antibody (Anti-IL-15 MAB)

Intervention Type BIOLOGICAL

Placebo

Placebo for AMG 714

Intervention Type BIOLOGICAL

nbUVB phototherapy

Participants will undergo narrow band ultraviolet B (nbUVB) phototherapy if their total body Vitiligo Area Scoring Index (T-VASI) does not improve by ≥ 25% at Week 24 compared to Week 0. Phototherapy will be administered in accordance with the Vitiligo Working Group expert recommendations.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

narrow band ultraviolet B phototherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adults 18-75 years of age.
2. Clinical diagnosis of active or stable vitiligo made by a dermatologist, as defined in Protocol Section 3.4.2.
3. F-VASI ≥ 0.25 (Appendix 2 of Protocol).
4. T-VASI ≥ 3 (Appendix 2 of Protocol).
5. Willingness to:

1. Undergo nbUVB phototherapy, as outlined in Protocol Section 7.3.
2. Stop all other treatments for vitiligo from screening through the final follow up visit as outlined in Protocol Section 7.2.

Exclusion Criteria

Individuals who meet any of the following criteria are not eligible for enrollment as study participants:

1. Inability or unwillingness of a participant to give written informed consent or comply with the study protocol.
2. Segmental vitiligo.
3. Contraindication to nbUVB phototherapy.
4. More than 33% leukotrichia on the face or on the total body.
5. Use of biologic immunosuppressive or immunomodulatory agents, or investigational therapy or procedure within 12 weeks or 5 half-lives prior to Visit 0 (whichever is longer), except agents authorized for prevention and treatment of SARS-CoV-2 infection according to FDA Emergency Use Authorization (EUA).
6. Use of laser or light-based treatment (phototherapy) including tanning beds within 8 weeks prior to Visit 0.
7. Use of non-biologic systemic or topical immunosuppressive or immunomodulatory agents within 4 weeks prior to Visit 0.
8. History of melanocyte-keratinocyte transplantation procedure (MKTP) or other surgical treatment for vitiligo.
9. Current or past use of the depigmenting agent monobenzyl ether of hydroquinone, including Benoquin® (Monobenzone).
10. Presence of skin conditions or lesions that would confound the vitiligo assessments.
11. Spontaneous repigmentation within 6 months prior to Visit 0 (repigmentation without any treatment and significant in amount as determined by the investigator).
12. Uncontrolled thyroid function at screening as determined by the investigator. If the participant has a history of thyroid disease and is on treatment, the participant must be on a stable thyroid regimen for at least three months prior to Visit 0.
13. Greater than 3 adequately treated nonmetastatic basal cell carcinomas (BCC) or squamous cell carcinomas (SCC) within 12 months prior to Visit 0; or previous history of multiple BCC or SCC which may pose additional risks from participation in the study in the opinion of the investigator.
14. Previous or current diagnosis of other cancer, except adequately treated cervical carcinoma in situ.
15. Acute or chronic infection, including current use of suppressive therapy for chronic infection, hospitalization for treatment of infection within 90 days prior to Visit 0, or parenteral anti-microbial (including anti-bacterial, anti-viral, or anti-fungal agents) use within 90 days prior to Visit 0.
16. Evidence of infection, including:

1. Human immunodeficiency virus (HIV)
2. Current or prior infection with hepatitis B (HBV), as indicated by positive HBsAg or positive HBcAb
3. Current or prior hepatitis C (HCV), unless treated with anti-viral therapy with achievement of a sustained virologic response (undetectable viral load 12 weeks after cessation of therapy)
4. Positive Quantiferon-TB Gold or Quantiferon-TB Gold Plus test. PPD or T-SPOT.TB test may be substituted for Quantiferon-TB Gold or Quantiferon-TB Gold Plus test
17. Any of the following laboratory abnormalities:

1. White blood count (WBC) \< 3.5 x 10\^3/μL
2. Hemoglobin \< 10 g/dL
3. Platelets (Plt) \< 125,000/mm\^3
4. Alanine aminotransferase (ALT) ≥ 2x ULN
5. Aspartate aminotransferase (AST) ≥ 2x ULN
18. Women of child-bearing potential who are unwilling to use a medically acceptable form of contraception or be sexually inactive by abstinence until study Week 48 (Protocol Section 7.4). Contraception or abstinence is required for 2 weeks prior to Visit 0.
19. Women who are pregnant or lactating.
20. Vaccination with a live attenuated vaccine within 30 days prior to Visit 0.
21. Known drug allergy or reaction to any component of AMG 714 (Protocol Section 6.1.1) or proteins derived from mammalian cell lines.
22. Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
23. Current, diagnosed mental illness (e.g. severe depression) or current, diagnosed or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No