An Open Label, Multi-centered, Randomized Phase 2 Study to Evaluate the Safety, Tolerability and Bioactivity of Subcutaneous ACTH GeL in PAtients With Scleritis: The ATLAS Study

Who is this study for? Patients with Scleritis
What treatments are being studied? ACTH (Adrenocorticotropic Hormone) Gel
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2

ATLAS study is a clinical trial to evaluate the potential role of subcutaneous adrenocorticotropic hormone (ACTH) gel in the management of non-infectious scleritis. Specifically, the ATLAS Study aims to evaluate the safety, tolerability and effect of 2 different dose regimens of ACTH gel administered by subcutaneous (SC) injection in patients with scleritis, over a period of 12 months. Scleritis is an inflammatory disease affecting the sclera (white outer coating of the eye), which causes blurring of vision, redness, tearing and painful ocular inflammatory episodes in one or both eyes. Scleritis may results in vision threatening ocular complications, if left untreated. Treatment of scleritis is usually chronic and requires systemic therapy with non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive therapy. Due to its treatment resistance nature, scleritis remains a therapeutic challenge for many ophthalmologists. H.P. Acthar Gel (ACTH Gel) is a highly purified preparation of adrenocorticotropic hormone (ACTH) in a gel that is designed to provide extended release of the ACTH following injection. It is a FDA approved treatment for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus), infantile spasms, adults with acute relapses or flares of multiple sclerosis (MS), patients with kidney diseases, among other indications. ACTH Gel is also approved for a wide range of allergic and inflammatory diseases of the eye. Given the established role of inflammation in the pathogenesis of scleritis and the anti-inflammatory effects of ACTH Gel treatment by blocking various inflammatory pathways, a beneficial outcome could be anticipated from ACTH Gel treatment in patients with scleritis.

Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No

• Adults, age ≥ 18 years;

• Able to give informed consent and attend all study visits;

• Have diagnosis of non-necrotizing scleritis determined by the Investigator to be non-infectious;

• Have active scleirits, defined as:

• Characteristic clinical presentation of active disease: painful inflammation, edema and tenderness to touch radiating to the forehead, the brow, the jaw, or the sinuses. Severity of pain associated with scleritis will be based on pain intensity, NRS scale.

• Scleral inflammation ranging from +1 to +3 as assessed by central reading center based on standardized scleritis grading scale.

• and:

• are receiving no other treatment; or,

• are receiving prednisone (or equivalent dose of another corticosteroid) and/or at least 1 other systemic immunosuppressant;

• Have anterior scleritis.

• Sufficient inflammation to require systemic treatment or long-term regional treatment.

• Subjects whom the investigators feel may only need short-term topical therapy should not be enrolled.

• Best-corrected visual acuity (ETDRS method) of 20/20 to 20/400 in the study eye;

• Best- corrected visual acuity (ETDRS method) of 20/400 or better in the fellow eye

• Must have a chest radiograph within 3 months prior to enrollment with no evidence of malignancy, infection or fibrosis.

• Females of childbearing potential must have a negative urine pregnancy test at screening. In addition, sexually active females of childbearing potential must agree to use TWO of the following adequate forms of contraception while on study medication: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner.

• Males must agree to use barrier contraception (latex condoms) when engaging in sexual activity while on study medication and for 28 days after taking the last dose of study medication.

• Prior to study screening, potential subjects must have been evaluated and screened for infectious etiologies by the investigators, possibly as part of standard clinical acre; all testing to rule out infectious causes must be performed within 3 months of screening for the ATLAS study.

• Currently active and uncontrolled scleritis, that at the determination of the investigator, requires the initiation of corticosteroid monotherapy (or equivalent), or prednisone therapy and immunomodulatory therapy or injections of corticosteroid (periocular); or scleritis in subjects for whom oral corticosteroid is contraindicated, relatively or absolutely.

• Evidence of active non-infectious scleral inflammation that at the determination of investigator requires therapy. Such evidence can be documented by clinical examination, photography, or ancillary testing (e.g. B-scan ultrasonography, fluorescein angiography, optical coherence tomography). As long as the investigator determines that the degree of inflammation can be monitored for regression or progression, the inflammation criterion can be met.

• Not planning to undergo elective ocular surgery during the first 6 months of the study.

• Subjects who have developed scleritis as ocular manifestation of an underlying systemic disease can be enrolled in the study only if the systemic therapy will not be altered throughout the study span. If at any point during the study, the ongoing systemic therapy needs to be altered (e.g. increase in the dose), the subject will have to exit the study.

• If scleritis is the initial manifestation of an underlying systemic disease, and the subjects need to be started on systemic therapy in the form of corticosteroids or immunomodulatory therapy for the underlying disease, then the subjects will not be eligible to participate in the study.

• Subjects with any or all of the following ocular complications associated with or secondary to scleritis may also be eligible for enrollment:

• Evidence of active anterior uveitis (defined as +1 cells or more in the anterior chamber or evidence of anterior vitreous inflammation on slit-lamp examination at presentation).

• Ocular hypertension, defined as intraocular pressure of ≥ 21 mmHg.

• Peripheral keratitis; defined as peripheral interstitial keratitis or thinning with either ulcerative or non-ulcerative component.10

• Subjects who have been on immunomodulatory therapy (IMT) prior to enrollment may participate in the study if they have been on a stable dose of IMT (at least 4 weeks with no change in IMT dosing or addition of new IMT agents).

United States
Byers Eye Institute, Stanford University
Palo Alto
New Jersey
Metropolitan Eye Research and Surgery Institute
Palisades Park
Foresight Studies, LLC
San Antonio
Contact Information
David S. Chu, MD
Atlas Study
Time Frame
Start Date: January 1, 2019
Estimated Completion Date: December 8, 2023
Target number of participants: 30
Experimental: Twice Weekly Treatment Arm
Patients in this treatment arm will receive mandatory 80 U twice weekly treatment with SC ACTH (adrenocorticotropic hormone) gel, starting at the Baseline visit (Day 0) until end of week 16. Starting at week 17, the treatment will be administered on as needed basis, based on the retreatment criteria.
Experimental: Thrice Weekly Treatment Arm
Patients in this treatment arm will receive mandatory 80 U thrice weekly treatment with SC ACTH (adrenocorticotropic hormone) gel, starting at the Baseline visit (Day 0) until end of week 16. Starting at week 16, the treatment will be administered on as needed basis, based on the retreatment criteria.
Mark S Dacey, Sanjay Kedhar, David S. Chu, Robert Wang, Quan D Nguyen, David K Scales, Henry Kaplan, Rajiv Shah, Kimberley Sippel
Collaborators: Ocular Imaging Research and Reading Center, Mallinckrodt, Foresight Studies, LLC, Stanford University
Leads: Metropolitan Eye Research & Surgery Institute

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