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

NCT03465111 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: #4301
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Scleritis; anterior; adrenocorticotropic hormone; ACTH; Non-infectious

Outcome Measures

Primary Outcomes (2)

• Change in grade of pain on an 11-point pain intensity numerical rating scale (NRS).

  The proportion of subjects demonstrating improvement (mean change from BL) by 5 points in pain, graded on an 11-point pain intensity numerical rating scale (NRS).

  At the primary end point (week 16) and at the end of follow-up period (week 52) or at time of rescue

• Change in degree of inflammation, based on the standardized scleritis grading scale.

  The proportion of subjects demonstrating improvement (mean change from BL) in inflammation (equal to or less than +0.5), based on the standardized scleritis grading scale.

  At the primary end point (week 16) and at the end of follow-up period (week 52) or at time of rescue

Secondary Outcomes (7)

• Best corrected visual acuity outcome

  At week 16 (primary end point) and week 52 (end of follow-up) after therapy

• Vascular leakage outcome

  At week 16 (primary end point) and week 52 (end of follow-up) after therapy

• Retinal thickness outcome

  At week 16 (primary end point) and week 52 (end of follow-up) after therapy

• Scleral thickness outcome

  At week 16 (primary end point) and week 52 (end of follow-up) after therapy

• Dosage of systemic corticosteroids outcome

  At week 16 (primary end point) and week 52 (end of follow-up) after therapy

Other Outcomes (2)

• Incidence and severity of ocular adverse events (AEs)

  At Baseline (BL) and monthly visits after screening

• Incidence and severity of other AEs

  At Baseline (BL) and monthly visits after screening

Study Arms (2)

Twice Weekly Treatment Arm

EXPERIMENTAL

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.

Drug: ACTH (adrenocorticotropic hormone) gel

Thrice Weekly Treatment Arm

EXPERIMENTAL

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.

Drug: ACTH (adrenocorticotropic hormone) gel

Interventions

ACTH (adrenocorticotropic hormone) gel DRUG

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

Also known as: H.P. Acthar® Gel

Thrice Weekly Treatment Arm; Twice Weekly Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any significant ocular disease that could compromise vision in the study eye. These include, but are not limited to:
• Diabetic retinopathy: proliferative diabetic retinopathy (PDR) or non-proliferative diabetic retinopathy (NPDR) that compromise the vision.
• Age-related macular degeneration;
• Myopic degeneration with active subfoveal choroidal neovascularization.
• Advanced glaucoma status post trabeculectomy or tube/valve placement
• Any of the following treatments within 90 days prior to Day 0 or anticipated use of any of the following treatments to the study eye:
• Intravitreal injections (including but not limited to steroids or anti-vascular endothelial growth factors);
• Posterior subtenon's steroids.
• Intraocular surgery within 90 days prior to Day 0 in the study eye;
• Capsulotomy within 30 days prior to Day 0 in the study eye;
• Any known ocular surgery (including cataract extraction or capsulotomy) of the study eye anticipated within the first 180 days following Day 0;
• Presence of posterior scleritis as the only type of scleritis (without concurrent presence of any type of anterior scleritis;
• Intraocular pressure ≥25 mmHg in the study eye (glaucoma subjects maintained on no more than 2 topical medications with IOP \<25 mmHg are allowed to participate);
• Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye;
• Media opacity that would limit clinical visualization;

Sponsors & Collaborators

• Metropolitan Eye Research & Surgery Institute: lead
• Mallinckrodt: collaborator
• Stanford University: collaborator
• Ocular Imaging Research and Reading Center: collaborator
• Foresight Studies, LLC: collaborator

Study Sites (3)

Byers Eye Institute, Stanford University

Palo Alto, California, 94303, United States

RECRUITING

Metropolitan Eye Research and Surgery Institute

Palisades Park, New Jersey, 07650, United States

RECRUITING

Foresight Studies, LLC

San Antonio, Texas, 78240, United States

RECRUITING

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MeSH Terms

Conditions

Scleritis

Interventions

Adrenocorticotropic Hormone; Gels

Condition Hierarchy (Ancestors)

Scleral Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• David S. Chu, MD

  Metropolitan Eye Research and Surgery Institute

  PRINCIPAL INVESTIGATOR

• Quan D Nguyen, MD, MSc

  Stanford University

  PRINCIPAL INVESTIGATOR

• David K Scales, MD

  Foresight Studies, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David S. Chu, MD

CONTACT

888-823-8808; uveitisnj@gmail.com

Atlas Study

CONTACT

atlasstudy@oirrc.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ATLAS is an Investigator-initiated, open-labelled, multi-center, randomized, phase II clinical trial, to evaluate the effect of two dose regimens of subcutaneous ACTH gel in subjects with non-infectious anterior scleritis. Thirty (30) subjects with non-infectious anterior scleritis will be enrolled and randomized (1:1) at their first visit to one of the two treatment arms: 1. Mandatory 80 U twice weekly treatment with SC ACTH 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. 2. Mandatory 80 U thrice weekly treatment with SC ACTH 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.

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: March 14, 2018
• Study Start: January 1, 2019
• Primary Completion: December 8, 2024
• Study Completion: December 8, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)