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

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:

1. A positive pregnancy test in women of childbearing potential;

2. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;

3. Neutrophils < 1.0 ×10^9/L;

4. Platelets < 75 ×10^9/L;

5. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal
Disease (MDRD) Study equation;

6. Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of
normal.

3. 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.