What side effects are associated with this type of intervention?

Common treatments for vitiligo include topical corticosteroids, ultraviolet radiation combined with topical preparations, and topical immunomodulators like pimecrolimus. Side effects of these treatments can include skin irritation, burning sensation, erythema, and an increased risk of skin cancer with prolonged UV exposure. For treatments similar to AMG 714, such as other monoclonal antibodies, side effects may include injection site reactions, increased risk of infections, and potential hypersensitivity reactions. Long-term safety data for these newer treatments are still lacking.

What prior FDA approvals exist?

As of the latest information, there are no FDA-approved drugs specifically for the treatment of vitiligo. Various treatments, including topical corticosteroids, ultraviolet light therapy, and immunomodulatory agents, have been explored, but none have received FDA approval. AMG 714, an anti-IL-15 monoclonal antibody, is currently being studied for its efficacy in treating vitiligo, but it has not yet been approved.

What other types of research exist?

Promising novel alternatives to AMG 714 for vitiligo patients include Janus kinase inhibitors such as tofacitinib, ruxolitinib, and baricitinib. These therapies are currently being studied for their efficacy in treating vitiligo by targeting immune pathways involved in the disease.

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Monoclonal Antibodies

AMG 714 for Vitiligo (REVEAL Trial)

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergo narrow band ultraviolet B (nbUVB) phototherapy

Adults 18-75 years of age

Must not have

Known drug allergy or reaction to any component of AMG 714 or proteins derived from mammalian cell lines

Previous or current diagnosis of other cancer, except adequately treated cervical carcinoma in situ

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12, week 24, week 36, week 48

Summary

This trial is testing AMG 714, a medication for adults with vitiligo. It works by blocking a protein that affects the immune system, potentially helping the skin regain its color.

Who is the study for?

Adults aged 18-75 with stable or active vitiligo, as diagnosed by a dermatologist. Participants must have had no new vitiligo lesions in the past 3 months for stable cases, and willingness to stop other treatments and undergo nbUVB phototherapy. Not eligible if using certain medications, have skin conditions that could affect assessments, history of cancer (with exceptions), infections like HIV/HBV/HCV/tuberculosis, segmental vitiligo, or uncontrolled thyroid issues.

What is being tested?

The trial is testing AMG 714's effectiveness on adults with vitiligo compared to a placebo while also receiving narrow band ultraviolet B (nbUVB) phototherapy. The goal is to see if AMG 714 can improve the skin condition better than no treatment alongside light therapy.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions related to immune system modulation such as inflammation or infection risk due to AMG 714 and typical side effects from nbUVB phototherapy like redness or irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am undergoing or will undergo nbUVB phototherapy.

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I am between 18 and 75 years old.

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I will stop all vitiligo treatments from the start of the study until week 48.

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My vitiligo has not changed or worsened in the last 3 months.

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I have been diagnosed with vitiligo by a dermatologist.

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I have been diagnosed with vitiligo by a skin doctor.

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I am willing to undergo nbUVB phototherapy treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to certain medications or components in AMG 714.

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I have had cancer before, but it wasn't cervical cancer that was treated.

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I cannot undergo narrowband UVB phototherapy due to health reasons.

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I have used skin lightening treatments like Benoquin®.

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I am not pregnant or breastfeeding.

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I have not received a live vaccine in the last 30 days.

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I don't have skin conditions that could affect vitiligo assessments.

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I have had more than 3 skin cancers treated in the last year.

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Over a third of my hair on my face or body is white.

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My thyroid function is not under control.

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I have had surgery for vitiligo.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12, week 24, week 36, week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12, week 24, week 36, week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12, week 24, week 36, week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥35 (F-VASI35) at Week 24

Secondary study objectives

Change from Baseline (Day 0) in Vitiligo Extent Score (VES) at Week 12, Week 24, Week 36, and Week 48

Change from Baseline (Day 0) in the Vitiligo Noticeability Scale (VNS) at Week 12, Week 24, Week 36, and Week 48

Change from Baseline (Day 0) in the Vitiligo Quality of Life (VitiQoL) at Week 12, Week 24, Week 36, and Week 48

+16 more

Other study objectives

EXPLORATORY: AMG 714 Serum Levels

EXPLORATORY: Time-to-Event Analysis of Participants Who Achieve a F-VASI35

EXPLORATORY: Time-to-Event Analysis of Participants Who Achieve total body Vitiligo Area Scoring Index ≥35 (T-VAS135)

Side effects data

From 2017 Phase 2 trial • 28 Patients • NCT02633020

42%

Nasopharyngitis

16%

Diarrhoea

16%

Headache

16%

Eosinophil count increased

11%

Asthenia

11%

Fatigue

11%

Cough

11%

Anaemia

11%

Eosinophilia

11%

Nausea

11%

Urinary tract infection

Helicobacter test positive

Eczema

Sleep disorder

Sinusitis

Lip exfoliation

Vomiting

Mouth ulceration

Pyrexia

Pharyngitis

Eosinophil count abnormal

Neutrophil count decreased

Hepatitis

Tuberculosis

Lip dry

Pneumococcal infection

Eye swelling

Abdominal pain

Balance disorder

Cerebellar syndrome

Visual impairment

Bronchitis viral

Respiratory tract infection

Alanine aminotransferase abnormal

Conjunctivitis

Blood alkaline phosphatase increased

Aspartate aminotransferase increased

Blood lactate dehydrogenase increased

Blood urine present

Dizziness postural

Chronic obstructive pulmonary disease

Dyspnoea exertional

Rosacea

Skin plaque

Rash

Iron deficiency

Paraesthesia

100%

80%

60%

40%

20%

Study treatment Arm

AMG 714

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AMG 714Experimental Treatment2 Interventions

Participants will be administered 300 mg AMG 714 subcutaneously on Day 0 and every 2 weeks thereafter through week 10 (for a total of 6 doses).

Group II: PlaceboPlacebo Group2 Interventions

Participants will be administered 300 mg AMG 714 subcutaneously on Day 0 and every 2 weeks thereafter through week 10 (for a total of 6 doses).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AMG 714

2007

Completed Phase 2

~120

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for vitiligo include topical corticosteroids, ultraviolet radiation, and narrowband UVB phototherapy. Topical corticosteroids work by reducing inflammation and modulating the immune response, which can help to halt the progression of depigmentation. Ultraviolet radiation, particularly narrowband UVB phototherapy, stimulates melanocyte activity and promotes repigmentation by inducing local immunosuppression and increasing melanocyte proliferation. These treatments are crucial for vitiligo patients as they address the underlying immune-mediated destruction of melanocytes, offering a chance for repigmentation and improved skin appearance. AMG 714, an anti-IL-15 monoclonal antibody, targets the IL-15 pathway, which is involved in the immune response. By inhibiting IL-15, AMG 714 may reduce the autoimmune attack on melanocytes, similar to how other treatments aim to modulate the immune system to preserve or restore pigmentation.

Vitiligo Skin Biomarkers Associated With Favorable Therapeutic Response.Unconventional Treatments for Vitiligo: Are They (Un) Satisfactory?Evidence-based management of vitiligo: summary of a Cochrane systematic review.