Refer a Patient

Do You Have a Patient With Diffuse Cutaneous Systemic Sclerosis (dcSSc)?

Study Purpose

The BEACON Study is evaluating the efficacy, safety and tolerability of an investigational medicine (HZN-825) that may slow disease progression in participants with dcSSc.

Study Design

The BEACON Study is a phase 2b, randomized, double-blind, placebo-controlled study. Approximately 300 participants will be enrolled in this study and randomized 1:1:1 to one of two HZN-825 dosing groups or the placebo group.

The total duration of participation is approximately 62 weeks and includes screening (up to six weeks), double-blind treatment (52 weeks) and a safety follow-up period (four weeks after the last dose of the investigational medicine). Background therapy for treatment of dcSSc will be allowed within protocol permissible limits. Participants who complete the 52-week double-blind treatment period may be eligible to enter a 52-week open-label extension study.

Primary Objective

The primary objective of this study is to demonstrate the efficacy of one or two dose regimens of HZN-825 versus placebo in participants with dcSSc, as determined by a comparison of change in forced vital capacity after 52 weeks of treatment.

A family eating lunch together in a park.

About the Investigational Medicine

HZN-825 is an oral lysophosphatidic acid receptor 1 (LPAR1) antagonist that prevents gene activation. In previous studies, LPAR1 antagonists significantly slowed the rate of decline in forced vital capacity tests, thus suggesting the potential for LPAR1 antagonists to be used as treatments for various fibrotic conditions.

To learn more about the HZN-825 compound and the mechanism of action, please watch the following video:

Key Inclusion Criteria

  • Male or female between the ages of 18 and 75 years (inclusive) at screening
  • Meets the 2013 American College of Rheumatology/European League Against Rheumatism classification for SSc with a total score of ≥ 9*
  • Classified as having skin involvement proximal to the elbow and/or knee (diffuse cutaneous SSc subset by LeRoy and Medsger, 2001)
  • At the time of enrollment, less than or equal to 72 months (six years) since the onset of the first SSc manifestation, other than Raynaud’s phenomenon
  • mRSS units ≥ 15 at Screening

*Van den Hoogen et al., 2013

Key Exclusion Criteria

  • Diagnosed with sine scleroderma or limited cutaneous SSc
  • Diagnosed with other autoimmune connective tissue diseases except for fibromyalgia, scleroderma-associated myopathy and secondary Sjögren’s syndrome
  • Scleroderma renal crisis diagnosed within six months of the screening visit
  • Use of any other non-steroid immunosuppressive agent, small biologic molecule, cytotoxic or anti-fibrotic drug within four weeks of screening. Exceptions include mycophenolate mofetil (CellCept®), mycophenolic acid (Myfortic®), methotrexate and low-dose prednisone or glucocorticoid equivalent

BEACON Study Research Sites

If you have a patient who may be interested in participating and may qualify, refer them to this study website to take the prescreening questionnaire to determine eligibility. You may also fill out a contact request form if you would like an active research site to reach out to you.

Find the Site Nearest You

Enter your zip code below or click on the map to find the participating research site(s) nearest you.

e.g., 12345

View full list of locations.

Active site locations

Future site locations