Uveitis Clinical Trial
Official title:
An Open-label, Multi-center, Randomized, Phase II Study of the Safety, and Bioactivity of Two Dose Regimens of Subcutaneous Injections of ACTH Gel in Patients With Non-infectious Uveitis
The study aims to evaluate the potential role of ACTH gel in the management of non-infectious uveitis.
Uveitis is a term used to describe a group of inflammatory disorders involving the uveal
tract (iris, ciliary body and choroid). It is amongst the most common causes in the list of
preventable cause of blindness in the developed world.
H.P. Acthar Gel is a highly purified sterile preparation of the adrenocorticotropic hormone
(ACTH) gelatin to provide a prolonged release after intramuscular or subcutaneous (SC)
injection.
ACTH is part of a group of molecules called melanocortins (MC) (ACTH, α, β, γ-MSH) that are
produced, in human bodies, by breakdown of a common larger precursor called
proopiomelanocortin (POMC). A very well-known anti-inflammatory mechanism of action of ACTH
is the production glucocorticoids by stimulating the adrenal glands. ACTH has also been shown
to bind with all five melanocortin receptors (MCRs). MCRs have a variety of roles including
cortisol production and regulation of immune modulation by ACTH.
ACTHAR is an open-label, multi-center, randomized, phase II study to evaluate the effect of
two dose regimens of repeated SC injections of ACTH gel in patients with active
non-infectious intermediate, posterior, or pan-uveitis followed over a period of 12 months.
ACTHAR study will be conducted at up to 7 clinical sites in USA. The study will be
coordinated by the Ocular Imaging Research and Reading Center (OIRRC), which will serve as
the coordinating and reading center for the ACTHAR Study.
The primary endpoint of the study will be at month 6, with an active, as-needed treatment
extension phase from month 6 to month 12.
Thirty-six (36) patients with non-infectious intermediate, posterior, or pan-uveitis will be
enrolled and randomized (1:1) to one of the two treatment arms:
1. Mandatory twice a week (Mondays and Thursdays) treatment with SC ACTH gel 80 U/day
starting at BL until month 6. Starting at month 6, the treatment will be administered on
as needed basis, based on the retreatment criteria.
2. Mandatory thrice a week (Mondays, Wednesdays, and Fridays) treatment with SC ACTH gel 80
U/day starting at BL until month 6. Starting at month 6, the treatment will be
administered on as needed basis, based on the retreatment criteria.
Starting at month 6, retreatment will be offered to study subjects who have demonstrated any
level of response during the first 6 months and who meet any of these Retreatment Criteria
listed below. Patients receiving retreatment will receive the dose that was assigned to them
at randomization.
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