AMG 714 for Vitiligo

(REVEAL Trial)

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

57 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment AMG 714 for vitiligo?

Research shows that combining narrowband ultraviolet B (nbUVB) therapy with other treatments, like apremilast, can improve repigmentation in vitiligo. This suggests that nbUVB, a component of the AMG 714 treatment, may help in treating vitiligo. ^{1 2 3 4 5}

How does the drug AMG 714 differ from other vitiligo treatments?

AMG 714 is unique because it targets specific immune pathways involved in vitiligo, potentially offering a novel approach compared to existing treatments like phototherapy or topical medications, which primarily focus on skin repigmentation. ^{3 6 7 8 9}

Research Team

Brett A. King, MD, PhD

Principal Investigator

Yale University School of Medicine: Department of Dermatology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: AMG 714 Experimental Treatment 2 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: Placebo Placebo Group 2 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).

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

Findings from Research

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Low-dose tofacitinib with 308-nm excimer therapy successfully induced repigmentation in patients with refractory vitiligo. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Prescribing and using vitiligo treatments: lessons from a nested process evaluation within the HI-Light vitiligo randomized controlled trial. [2022]

3. Germany 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. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Guidelines for the treatment of vitiligo. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Treatment of stable nonsegmental vitiligo using transdermal delivery of 5-fluorouracil by fractional CO2 laser versus intralesional injection of 5-fluorouracil, both followed by narrow-band type ultraviolet B (UVB): A comparative study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Drug-induced vitiligo: a case/non-case study in Vigibase® , the WHO pharmacovigilance database. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Comparison between 308-nm monochromatic excimer light and narrowband UVB phototherapy (311-313 nm) in the treatment of vitiligo--a multicentre controlled study. [2007]

8. Switzerland 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. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Individualized Homeopathic Medicines in Treatment of Vitiligo: Double-Blind, Randomized, Placebo-Controlled Pilot Trial. [2022]