AMG 714 for Vitiligo

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
VitiligoAMG 714 - Biological
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

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

Video Summary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 19 Secondary · Reporting Duration: Week 12, Week 24, Week 36, Week 48

Up to 48 Weeks
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)
Up to Week 48
Occurrence of ≥ Grade 2 Adverse Events (AEs)
Occurrence of ≥ Grade 3 Infectious Adverse Events (AEs)
Week 48
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥25 (F-VASI25) at Week 12, Week 24, Week 36 and Week 48
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥50 (F-VASI50) at Week 12, Week 24, Week 36 and Week 48
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥75 (F-VASI75) at Week 12, Week 24, Week 36 and Week 48
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥90 (F-VASI90) at Week 12, Week 24, Week 36 and Week 48
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥25 (T-VASI25) at Week 12, Week 24, Week 36 and Week 48
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥35 (T-VASI35) at Week 12, Week 24, Week 36 and Week 48
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥50 (T-VASI50) at Week 12, Week 24, Week 36 and Week 48
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥75 (T-VASI75) at Week 12, Week 24, Week 36 and Week 48
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥90 (T-VASI90) at Week 12, Week 24, Week 36 and Week 48
Week 48
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
Change from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI) at Week 12, Week 24, Week 36, and Week 48
Change from Baseline in Face Vitiligo Area Scoring Index (F-VASI) at Week 12, Week 24, Week 36, and Week 48
Percentage Change from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI) at Week 12, Week 24, Week 36, and Week 48
Percentage Change from Baseline in Face Vitiligo Area Scoring Index (F-VASI) at Week 12, Week 24, Week 36, and Week 48
Week 48
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥35 (F-VASI35) at Week 12, Week 36, Week 48
Week 24
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥35 (F-VASI35) at Week 24
Week 6, Week 12
EXPLORATORY: AMG 714 Serum Levels

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Side Effects for

AMG 714
42%Nasopharyngitis
16%Diarrhoea
16%Headache
16%Eosinophil count increased
11%Asthenia
11%Anaemia
11%Fatigue
11%Urinary tract infection
11%Eosinophilia
11%Nausea
11%Cough
5%Helicobacter test positive
5%Skin plaque
5%Bronchitis viral
5%Sinusitis
5%Hepatitis
5%Pneumococcal infection
5%Blood urine present
5%Eczema
5%Conjunctivitis
5%Aspartate aminotransferase increased
5%Rosacea
5%Eosinophil count abnormal
5%Paraesthesia
5%Neutrophil count decreased
5%Vomiting
5%Iron deficiency
5%Blood lactate dehydrogenase increased
5%Sleep disorder
5%Visual impairment
5%Pyrexia
5%Rash
5%Respiratory tract infection
5%Pharyngitis
5%Tuberculosis
5%Lip dry
5%Balance disorder
5%Abdominal pain
5%Cerebellar syndrome
5%Mouth ulceration
5%Lip exfoliation
5%Eye swelling
5%Alanine aminotransferase abnormal
5%Dizziness postural
5%Blood alkaline phosphatase increased
5%Chronic obstructive pulmonary disease
5%Dyspnoea exertional
This histogram enumerates side effects from a completed 2017 Phase 2 trial (NCT02633020) in the AMG 714 ARM group. Side effects include: Nasopharyngitis with 42%, Diarrhoea with 16%, Headache with 16%, Eosinophil count increased with 16%, Asthenia with 11%.

Trial Design

2 Treatment Groups

AMG 714
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

57 Total Participants · 2 Treatment Groups

Primary Treatment: AMG 714 · Has Placebo Group · Phase 2

AMG 714Experimental Group · 2 Interventions: AMG 714, nbUVB phototherapy · Intervention Types: Biological, Procedure
PlaceboPlaceboComparator Group · 2 Interventions: nbUVB phototherapy, Placebo · Intervention Types: Procedure, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ordesekimab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 12, week 24, week 36, week 48

Who is running the clinical trial?

Rho Federal Systems Division, Inc.Industry Sponsor
39 Previous Clinical Trials
15,196 Total Patients Enrolled
Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,842 Total Patients Enrolled
PPDIndustry Sponsor
148 Previous Clinical Trials
31,485 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,151 Previous Clinical Trials
4,959,885 Total Patients Enrolled
AmgenIndustry Sponsor
1,296 Previous Clinical Trials
1,328,761 Total Patients Enrolled
Brett A. King, MD, PhDStudy ChairYale University School of Medicine: Department of Dermatology

Eligibility Criteria

Age 18 - 75 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A person with active vitiligo has new or expanding lesions on their skin that may have a confetti, trichrome, or inflammatory pattern, or other signs of active vitiligo
The facial vitiligo area scoring index is ≥0.25.
A person has total body vitiligo if the Total Body Vitiligo Area Scoring Index (T- VASI) is ≥3.
The participant must be able to understand what is happening and provide consent that is informed.
The person has not developed any new depigmented patches, and no confetti, trichrome, or inflammatory vitiligo lesions in the past 3 months.
Receive a type of light therapy that uses a narrow band of ultraviolet light.
Do not start any other treatments for vitiligo until the final follow-up visit at week 48 is over.

Who else is applying?

What state do they live in?
Florida50.0%
Washington50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Yale University School of Medicine: Department of Dermatology50.0%
University of Texas at Austin: Department of Dermatology50.0%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%