AMG 714 for Vitiligo

(REVEAL Trial)

No longer recruiting at 9 trial locations

Overseen By Iltefat Hamzavi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Biologics, Immunosuppressants, Monobenzone, others

Disqualifiers: Segmental vitiligo, Cancer, Infections, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 18

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AMG 714 to determine its effectiveness for vitiligo, a condition causing patches of skin to lose color. Participants will receive injections of either AMG 714 (an experimental treatment) or a placebo (a harmless substance resembling the treatment) to compare effects. The trial seeks adults with vitiligo who have completed their COVID-19 vaccinations and are willing to pause other vitiligo treatments during the study. Those meeting these criteria may find this trial suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

Yes, you will need to stop all other treatments for vitiligo from the screening through the final follow-up visit. The protocol does not specify about other medications, so it's best to discuss with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have tested AMG 714 and found it to be generally well-tolerated. This treatment is a special protein designed to target certain cells and has been used in trials for conditions like celiac disease. During these trials, some participants experienced side effects, mostly mild to moderate, such as headaches and injection site reactions like redness or swelling.

Since at least one previous trial has tested AMG 714 in humans, there is some evidence of its safety. However, any treatment can affect individuals differently. Prospective participants should discuss potential risks and benefits with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for vitiligo?

Most treatments for vitiligo, like corticosteroids and topical calcineurin inhibitors, aim to reduce inflammation and encourage repigmentation. But AMG 714 works differently, targeting IL-15, a protein believed to play a key role in the autoimmune response that causes vitiligo. This new mechanism of action could potentially offer a more direct approach to addressing the underlying cause of the condition. Researchers are excited about AMG 714 because it offers hope for more effective and targeted treatment options for those living with vitiligo.

What evidence suggests that AMG 714 might be an effective treatment for vitiligo?

Research has shown that AMG 714, a type of medication, may help treat vitiligo. In one study with 12 patients who had hard-to-treat vitiligo, 7 experienced an average improvement of 51.4% in skin color. This suggests that AMG 714 might help some people regain their skin color. Participants in this trial may receive AMG 714, which has generally been safe to use, with manageable side effects. Overall, these findings offer hope for those with vitiligo seeking new treatment options. ^{1 2 3 4 6}

Who Is on the Research Team?

Brett A. King, MD, PhD

Principal Investigator

Yale University School of Medicine: Department of Dermatology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had new or worsening vitiligo spots in the last 3 months.

I am undergoing or will undergo nbUVB phototherapy.

Your T-VASI score is 3 or higher.

Exclusion Criteria

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

I haven't used any immune system altering drugs in the last 4 weeks.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 300 mg AMG 714 subcutaneously on Day 0 and every 2 weeks through week 10

10 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

38 weeks

Regular assessments at Week 12, Week 24, Week 36, and Week 48

What Are the Treatments Tested in This Trial?

Interventions

• AMG 714
• nbUVB phototherapy
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: AMG 714 Experimental Treatment 2 Interventions

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 II: Placebo Placebo Group 2 Interventions

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).

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Rho Federal Systems Division, Inc.

Industry Sponsor

Trials

44

Recruited

15,000+

Immune Tolerance Network (ITN)

Collaborator

Trials

68

Recruited

7,900+

PPD

Industry Sponsor

Trials

162

Recruited

36,600+

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD Development, LP

Industry Sponsor

Published Research Related to This Trial

The combination of apremilast and narrowband UVB therapy significantly reduces immune cell markers (like CD8+ T cells) and enhances melanogenesis markers in vitiligo skin, suggesting a more effective treatment approach than narrowband UVB alone.

This study supports the clinical observation that apremilast can enhance the repigmentation effects of narrowband UVB therapy in patients with generalized vitiligo, particularly in skin types IV-VI, although it was limited by a small sample size and high dropout rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apremilast and narrowband ultraviolet B combination therapy suppresses Th17 axis and promotes melanogenesis in vitiligo skin: a randomized, split-body, pilot study in skin types IV-VI. Kim, HJ., Del Duca, E., Pavel, AB., et al.[2023]

Combining low-dose tofacitinib with 308-nm excimer laser treatment shows promise as an effective therapy for patients with nonsegmental vitiligo who have not responded to standard treatments.

This combination therapy could offer a new option for patients struggling with vitiligo, potentially improving their skin condition when other therapies have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose tofacitinib with 308-nm excimer therapy successfully induced repigmentation in patients with refractory vitiligo. Fang, WC., Lin, SY., Huang, SM., et al.[2022]

The study identified a significant association between vitiligo and several drugs, particularly immune checkpoint inhibitors like pembrolizumab and nivolumab, with reporting odds ratios indicating a strong link to vitiligo occurrence.

New associations were also found with selective immunosuppressants such as alemtuzumab and interleukin inhibitors, suggesting that these classes of drugs may contribute to the development of vitiligo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-induced vitiligo: a case/non-case study in Vigibase® , the WHO pharmacovigilance database. Anthony, N., Bourneau-Martin, D., Ghamrawi, S., et al.[2021]

In a study involving 11 vitiligo patients, localized 311-nm narrow-band ultraviolet B (NB-UVB) treatment resulted in over 50% repigmentation in 20% of the lesions, demonstrating its effectiveness for vitiligo.

In contrast, the 308-nm monochromatic excimer light (MEL) treatment did not achieve any lesions with more than 50% repigmentation after 24 sessions, indicating that NB-UVB is a superior option for localized vitiligo treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrapatient comparison of 308-nm monochromatic excimer light and localized narrow-band UVB phototherapy in the treatment of vitiligo: a randomized controlled trial. Verhaeghe, E., Lodewick, E., van Geel, N., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04338581

NCT04338581 | Evaluation of AMG 714 for Vitiligo This study is designed to evaluate the efficacy of AMG 714 for the treatment of adult participants with vitiligo.

2. vrfoundation.org vrfoundation.org/trials/evaluation-of-amg-714-for-vitiligo-reveal

Evaluation of AMG 714 for Vitiligo (REVEAL) A Phase 2 clinical study evaluating the efficacy and safety of AMG 714, an anti-IL-15 monoclonal antibody, in adults with vitiligo.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11291099/

Up-and-Coming Drugs for the Treatment of Vitiligo - PMC In 12 patients with recalcitrant vitiligo, 7 patients presented an average improvement in pigmentation of 51.4% without relevance to age, sex, disease duration, ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/81/NCT04338581/Prot_SAP_000.pdf

Protocol ITN086AI Evaluation of AMG 714 for Vitiligo In summary, AMG 714 was well tolerated in the completed clinical trials and has demonstrated an acceptable safety profile. 1.4.2 Clinical ...

5. trial.medpath.com trial.medpath.com/clinical-trial/887ca736f9c538f3/nct04338581-evaluation-amg-714-vitiligo

Evaluation of AMG 714 for Vitiligo | MedPath ≥90% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score. Proportion of Participants Achieving Face Vitiligo Area Scoring Index ...

6. withpower.com withpower.com/trial/phase-3-vitiligo-11-2020-e79d8

AMG 714 for Vitiligo (REVEAL Trial) Prior Safety DataThis treatment has passed at least one previous human trial ... What data supports the effectiveness of the treatment AMG 714 for vitiligo?