NCT03713320.

Study name	SOLAR: A Phase 2, randomized, open‐label, parallel‐group, active comparator, ,ulti‐center study to investigate the efficacy and aafety of cobomarsen (MRG‐106) in subjects with cutaneous T‐cell lymphoma (CTCL), Mycosis Fungoides (MF) Subtype
Methods	This is a randomised controlled trial comparing cobomarsen vs. vorinostat in patients with mycosis fungoides.
Participants	Inclusion criteria Biopsy‐proven CTCL, MF subtype Clinical stage IB, II, or III, with staging based on screening assessments Minimum Severity Weighted Assessment Tool (mSWAT) score of 10 at screening Receipt of at least one prior therapy for CTCL Exclusion criteria Previous enrolment in a cobomarsen study Prior therapy with vorinostat or other HDAC inhibitors, or contraindication to an HDAC inhibitor Sézary syndrome or mycosis fungoides with B2 involvement, defined as documented history of B2 and/or B2 staging at screening Evidence of large cell transformation Lymph node involvement at screening, unless radiologically‐ or histologically‐confirmed to be non malignant Visceral involvement related to MF at screening
Interventions	Arm I At least weekly doses of cobomarsen throughout study treatment period. Arm II Daily doses of vorinostat throughout study treatment period.
Outcomes	Primary outcomes of the study Proportion of participants achieving an objective response of at least 4 months duration (ORR4) based on composite global response criteria including radiological imaging, flow cytometry, and the modified Severity Weighted Assessment Tool (mSWAT). Secondary outcomes of the study Progression‐free survival Pruritus Numerical Rating Scale Skindex‐29 Dermatological Survey Pain Numerical Rating Scale Difference in drug tolerability by weekly patient impression of treatment side effects Duration of composite global response for responding subjects Complete response rate Skin disease severity based on modified Severity‐weighted Assessment Tool (mSWAT) Time to progression Overall survival Number of participants with treatment‐related adverse events as assessed by CTCAE v5.0 Plasma concentration of cobomarsen
Starting date	2018
Contact information	Sponsors and collaborators miRagen Therapeutics, Inc. Investigators Principal Investigator: Christiane Querfeld
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