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Monoclonal Antibodies

AMG 714 for Vitiligo (REVEAL Trial)

Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12, week 24, week 36, week 48
Awards & highlights

REVEAL Trial Summary

This trial will test whether AMG 714 can improve vitiligo in adults.

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.Check my eligibility
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.See study design
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.

REVEAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am undergoing or will undergo nbUVB phototherapy.
Select...
I am between 18 and 75 years old.
Select...
I will stop all vitiligo treatments from the start of the study until week 48.
Select...
My vitiligo has not changed or worsened in the last 3 months.
Select...
I have been diagnosed with vitiligo by a dermatologist.
Select...
I have been diagnosed with vitiligo by a skin doctor.
Select...
I am willing to undergo nbUVB phototherapy treatment.

REVEAL Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥35 (F-VASI35) at Week 24
Secondary outcome measures
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 outcome measures
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%
Eosinophil count increased
16%
Headache
11%
Eosinophilia
11%
Anaemia
11%
Nausea
11%
Asthenia
11%
Fatigue
11%
Urinary tract infection
11%
Cough
5%
Cerebellar syndrome
5%
Tuberculosis
5%
Iron deficiency
5%
Visual impairment
5%
Abdominal pain
5%
Lip exfoliation
5%
Dizziness postural
5%
Eczema
5%
Rash
5%
Mouth ulceration
5%
Blood alkaline phosphatase increased
5%
Alanine aminotransferase abnormal
5%
Dyspnoea exertional
5%
Neutrophil count decreased
5%
Rosacea
5%
Skin plaque
5%
Bronchitis viral
5%
Conjunctivitis
5%
Hepatitis
5%
Pneumococcal infection
5%
Lip dry
5%
Vomiting
5%
Pyrexia
5%
Pharyngitis
5%
Respiratory tract infection
5%
Sinusitis
5%
Aspartate aminotransferase increased
5%
Blood lactate dehydrogenase increased
5%
Blood urine present
5%
Eosinophil count abnormal
5%
Helicobacter test positive
5%
Paraesthesia
5%
Sleep disorder
5%
Chronic obstructive pulmonary disease
5%
Balance disorder
5%
Eye swelling
100%
80%
60%
40%
20%
0%
Study treatment Arm
AMG 714
Placebo

REVEAL 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

Find a Location

Who is running the clinical trial?

Rho Federal Systems Division, Inc.Industry Sponsor
41 Previous Clinical Trials
13,552 Total Patients Enrolled
AmgenIndustry Sponsor
1,371 Previous Clinical Trials
1,378,049 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,412 Total Patients Enrolled

Media Library

AMG 714 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04338581 — Phase 2
Vitiligo Research Study Groups: AMG 714, Placebo
Vitiligo Clinical Trial 2023: AMG 714 Highlights & Side Effects. Trial Name: NCT04338581 — Phase 2
AMG 714 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04338581 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Washington
New York
Other
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Yale University School of Medicine: Department of Dermatology
Henry Ford Health System
University of Texas at Austin: Department of Dermatology
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
0

What questions have other patients asked about this trial?

How long is the trial? How many trips to Austin will I be taking? How long of a trial is this, what are the inherent risks, is there any form of compensation for the drive out there besides a possible resolution to the Vitiligo, are the trips out to there going to be for prolonged periods of time or relatively quick, and lastly, when does this start if I am chosen?
PatientReceived no prior treatments

Why did patients apply to this trial?

Currently experiencing active spreading of vitiligo. I’ve tried most treatments and have non-segmental vitiligo.
PatientReceived 2+ prior treatments
I have not received any treatment and condition is getting worse. I'm ready to leave my house and get back into some form of socialization.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Yale University School of Medicine: Department of Dermatology: < 48 hours
Average response time
  • < 2 Days
~5 spots leftby Sep 2024