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AMG 714 for Vitiligo (REVEAL Trial)
REVEAL Trial Summary
This trial will test whether AMG 714 can improve vitiligo in adults.
REVEAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowREVEAL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 2 trial • 28 Patients • NCT02633020REVEAL Trial Design
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Who is running the clinical trial?
Media Library
- 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 new or worsening vitiligo spots in the last 3 months.I have had cancer before, but it wasn't cervical cancer that was treated.I haven't used any immune-modifying drugs or experimental treatments recently.You have a current infection with HIV, hepatitis B, hepatitis C, or tuberculosis.I am undergoing or will undergo nbUVB phototherapy.Your T-VASI score is 3 or higher.You have a specific type of vitiligo called segmental vitiligo.Abnormal results in blood tests or other lab tests.I cannot undergo narrowband UVB phototherapy due to health reasons.I have used skin lightening treatments like Benoquin®.I am not pregnant or breastfeeding.My skin has started to regain color on its own in the last 6 months.I have not received a live vaccine in the last 30 days.I am willing to use birth control or remain abstinent until study Week 48.I have health issues that could increase my risk in a study.I am between 18 and 75 years old.Your F-VASI score is greater than or equal to 0.25.I completed my initial COVID-19 vaccination series over 14 days ago.I am willing to undergo nbUVB phototherapy as required.I will stop all vitiligo treatments from the start of the study until week 48.My vitiligo has not changed or worsened in the last 3 months.Criterion: Your F-VASI score is 0.25 or higher.Your T-VASI score is 3 or higher.I have been diagnosed with vitiligo by a dermatologist.I don't have skin conditions that could affect vitiligo assessments.I have had more than 3 skin cancers treated in the last year.I haven't used any laser or light treatments, including tanning beds, in the last 8 weeks.I have been diagnosed with vitiligo by a skin doctor.Over a third of my hair on my face or body is white.My thyroid function is not under control.You have a current diagnosed mental illness or are currently using drugs or alcohol excessively.I have had surgery for vitiligo.I am willing to undergo nbUVB phototherapy treatment.I have not been hospitalized or used strong antibiotics for an infection in the last 3 months.
- Group 1: AMG 714
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has there ever been a similar study conducted before?
"Provention Bio, Inc. initiated the initial inquiry into AMG 714 in 2020, a study involving 220 patients which granted phase 2 drug approval. Currently, there are two ongoing studies throughout 46 cities and 4 countries exploring this medication's efficacy."
What is the cap imposed on participation in this clinical investigation?
"Confirmed. According to the information posted on clinicaltrials.gov, this research is actively seeking participants and was initially published on December 11th 2020. A total of 57 individuals need to be enrolled from 9 distinct medical locations."
What potential risks and side effects should patients be aware of regarding AMG 714?
"Based on the available evidence, AMG 714 is provisionally rated a 2 regarding safety. This rating reflects that this trial is in Phase 2, indicating that there are some data points validating security but no proof of efficacy yet."
In what quantity of sites is this research experiment active?
"Nine medical facilities are providing enrolment for this trial, with University of Massachusetts Medical School in Worcester, University of California, Irvine in Irvine and Tufts Medical Center: Department of Dermatology in Boston being some key examples."
Is this medical experiment still welcoming new participants?
"Affirmative, according to clinicaltrials.gov the trial is now accepting applications; its initial posting date was December 11th 2020 and there has been a modification as recent as November 14th 2022. This research effort requires 57 participants from 9 different medical facilities."
Is there an opportunity to participate in this research program?
"This trial is recruiting 57 individuals aged 18-75 who possess existing vitiligo. To be eligible, candidates must meet the following conditions: demonstrate indications of active or inactive Vitiligo in the last three months; receive narrow band ultraviolet B (nbUVB) phototherapy only throughout this study's duration; and suspend all other treatments for their condition from screening up to week 48."
Is the age limit for enrollees in this experiment higher than 25 years?
"This clinical trial is looking for patients within the age range of 18 and 75 years old."
What have previous investigations revealed concerning AMG 714?
"At present, two ongoing clinical trials are investigating AMG 714 with 0 in the Phase 3 stage. Many of these research sites are located in Dublin, Ohio, but there is a total of 55 centres around the world involved in this project."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Yale University School of Medicine: Department of Dermatology: < 48 hours
Average response time
- < 2 Days
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