Welcome to the REVEAL Study
The primary goal of the REVEAL study is to determine whether the experimental study medication, AMG 714, can bring back normal color to the skin (repigmentation) in vitiligo.
About AMG 714
AMG 714 is an antibody, like the ones your body makes, but this antibody has been made in the laboratory. AMG 714 is an experimental drug that interferes with IL-15, a chemical signal for the tissue resident memory (Trm) immune cells that are thought to be part of the attack on pigment-producing melanocytes in vitiligo skin. Interfering with IL-15 signaling using AMG 714 may stop the immune system’s attack on melanocytes and allow the melanocytes to produce normal color in the skin (repigmentation).
Participating in the REVEAL Study
Eligible participants will be randomly assigned to one of two groups. One group will receive the study drug, AMG 714, and the other group will receive an inactive substance made to look like the study drug, called a placebo.
Two-thirds of the participants will receive AMG 714. One-third of the participants will receive placebo. You cannot choose your group. A computer randomly picks who gets the study drug and who gets placebo.
This study is double-blinded, which means that during the study, neither you nor your study doctor will know who is receiving AMG 714 or placebo.
You will come for a screening visit to see if you are eligible to participate. Eligible participants will come for study visits as summarized below:
|Treatment Period||3 months (12 weeks), consisting of 6 clinic visits with subcutaneous doses every 2 weeks|
Approximately 8 months (36 weeks), during which there are 5 clinic visits
Narrowband UVB Phototherapy
Participation in the REVEAL study may also require Narrowband Ultraviolet B light (nbUVB) phototherapy treatment for approximately 24 weeks. If nbUVB phototherapy treatment is required, it will begin within 4 weeks after study week 24 and continue until study week 48.
Phototherapy can be given in a phototherapy clinic/center or using a home-based nbUVB phototherapy unit. The decision whether to have nbUVB phototherapy in a phototherapy clinic/center or at home will made by the participant in consultation with their study doctor.
Participants who receive nbUVB phototherapy at home will be given a home-based UVB phototherapy unit to use until the end of the study. Daavlin, a home phototherapy equipment provider, will arrange delivery and set up of a pre-programmed phototherapy unit. See the video below and related PDF printable information regarding the Daavlin 7 Series phototherapy unit delivery/return, set-up and user instructions.