Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

For people ages 18 years and up

Key Inclusion Criteria:

1. ≥ 18 years of age at the time Informed Consent is signed.
2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).
3. Disease duration ≤ 6 years from the first non-Raynaud's symptom.
4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.

Key Exclusion Criteria:

1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.
2. Any of the following values for laboratory tests at Screening:
3. A positive pregnancy test in women of childbearing potential;
4. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;

5. Neutrophils < 1.0 ×10⁹/L;

6. Platelets < 75 ×10⁹/L;

7. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;
8. Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of normal.
9. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.