A Clinical Study to Evaluate the Potential Role of ACTH Gel in Patients With Scleritis

Summary

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.

Conditions

• Scleritis

Interventions

DRUG

ACTH (adrenocorticotropic hormone) gel

The dose of H.P. Acthar Gel is 80 Units administered subcutaneously

Sponsors & Collaborators

• Mallinckrodt

  collaborator INDUSTRY

• Stanford University

  collaborator OTHER

• Ocular Imaging Research and Reading Center

  collaborator OTHER

• Foresight Studies, LLC

  collaborator OTHER

• Metropolitan Eye Research & Surgery Institute

  lead OTHER

Principal Investigators

• David S. Chu, MD · Metropolitan Eye Research and Surgery Institute

• Quan D Nguyen, MD, MSc · Stanford University

• David K Scales, MD · Foresight Studies, LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2024-12-08

Completion

2024-12-08

FDA Drug

Yes

Countries

• United States

Study Locations