9 completed, 3 terminated. 8 Phase 2, 4 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 7, Terminated 1 |
| Phase 3 | 4 | Completed 2, Terminated 2 |
| Phase 1 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL Hypericin, Placebo - CTCL/ Mycosis Fungoides, CTCL | Phase 3 | Terminated | Soligenix | 70 | 2025-01-07 | 2026-07-13 |
| Dusquetide for the Treatment of Behcet's Disease Dusquetide - Behçet Disease | Phase 2 | Completed | Soligenix | 8 | 2024-11-18 | 2026-08-26 |
| HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL Hypericin, Mechlorethamine Topical Gel - Cutaneous T-Cell Lymphoma/Mycosis Fungoides | Phase 2 | Completed | Soligenix | 10 | 2023-12-05 | 2025-08-20 |
| Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light Hypericin, Visible Light - Cutaneous T Cell Lymphoma, Mycosis Fungoides | Phase 2 | Completed | Ellen Kim, MD | 10 | 2023-08-21 | 2026-02-09 |
| Topical SGX302 for Mild-to-Moderate Psoriasis Hypericin - Psoriasis, Plaque Psoriasis | Phase 2 | Completed | Soligenix | 15 | 2022-12-14 | 2026-08-13 |
| PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma Hypericin - Cutaneous T-Cell Lymphoma/Mycosis Fungoides | Phase 2 | Completed | Soligenix | 9 | 2022-05-09 | 2023-06-07 |
| DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer SGX942, Placebo - Squamous Cell Carcinoma of the Oral Cavity and Oropharynx, Oral Mucositis | Phase 3 | Completed | Soligenix | 266 | 2017-12-04 | 2022-11-08 |
| FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) SGX301 (synthetic hypericin), Placebo - Cutaneous T-Cell Lymphoma | Phase 3 | Completed | Soligenix | 169 | 2015-12-01 | 2022-04-15 |
| A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer SGX942, Placebo - Oral Mucositis | Phase 2 | Completed | Soligenix | 111 | 2013-12-01 | 2017-08-28 |
| Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD) orBec, Placebo - Chronic Gastrointestinal Graft vs Host Disease | Phase 2 | Terminated | Soligenix | 2 | 2013-12-01 | 2018-11-01 |
| A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal Cancer SGX201 (delayed release beclomethasone 17,21-dipropionate) - Enteritis | Phase 1 / Phase 2 | Completed | Soligenix | 16 | 2009-12-01 | 2012-12-17 |
| Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD) oral beclomethasone 17,21-dipropionate, Placebo - Acute Gastrointestinal Graft vs Host Disease | Phase 3 | Terminated | Soligenix | 140 | 2009-10-01 | 2013-12-06 |
Mycosis Fungoides (5) · Lymphoma, T-Cell, Cutaneous (3) · Stomatitis (2) · Behcet Syndrome (1) · Carcinoma, Squamous Cell (1) · Enteritis (1) · Head and Neck Neoplasms (1) · Psoriasis (1) · Squamous Cell Carcinoma of Head and Neck (1)
hypericin (6) · dusquetide (2) · Amines (1) · Light (1) · TNTCFP protein (1) · alpha-ketoisovalerate dehydrogenase phosphatase (1)
United States (11) · Belgium (1) · France (1) · Spain (1) · Turkey (Türkiye) (1) · United Kingdom (1)
David Hockenbery, MD (1) · Keith Sullivan, MD (1) · Kevin Horgan, MD (1)
PMID 32632956, PMID 35857290, PMID 41400947, PMID 41920467
R43CA141968 (1)