HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL

NCT06149247 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HPN-CTCL-04
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment.

Conditions

Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Keywords

CTCL; MF; Hypericin; HyBryte

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score

  A treatment response is defined as a ≥50% improvement in mCAILS score at Week 12 when compared to the mCAILS score at baseline. The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome.

  12 weeks

Study Arms (2)

HyBryte (0.25 % hypericin)

EXPERIMENTAL

HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 6 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 12 weeks.

Drug: Hypericin

Valchlor (mechlorethamine)

ACTIVE COMPARATOR

Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks.

Drug: Mechlorethamine Topical Gel

Interventions

Hypericin DRUG

HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.

Also known as: HyBryte, SGX301

HyBryte (0.25 % hypericin)

Mechlorethamine Topical Gel DRUG

Valchlor is an FDA-approved drug for the treatment of CTCL.

Also known as: Valchlor

Valchlor (mechlorethamine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum of 3 active treatment-accessible CTCL lesions
• Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IA, IB, or Stage IIA
• Subjects willing to follow the clinical protocol and voluntarily give their written informed consent
• Female subjects not pregnant nor nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation

You may not qualify if:

• History of severe allergic reaction to any of the components of HyBryte or mechlorethamine (Valchlor)
• Pregnancy or mothers who are breast-feeding
• All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception
• Subjects with history of sun hypersensitivity or photosensitive dermatoses (eg, porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)
• Subjects whose condition is spontaneously improving
• Subjects receiving Valchlor (or any topical compound containing Mechlorethamine) in the preceding 2 months
• Subjects receiving topical steroids or other topical treatments (eg, targretin gel) on treatment accessible lesions for CTCL within 2 weeks of enrollment
• Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
• Subjects who have received electron beam irradiation within 3 months of enrollment
• Subjects with a history of significant systemic immunosuppression
• Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
• Subject has any condition that, in the judgment of the Investigator, is likely to interfere with participation in the study
• Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks

Sponsors & Collaborators

• Soligenix: lead

Study Sites (1)

Rochester Skin Lymphoma Medical Group

Fairport, New York, 14450, United States

Location

MeSH Terms

Conditions

Mycosis Fungoides

Interventions

hypericin; Amines

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals

Results Point of Contact

• Title: Richard Straube, MD/Chief Medical Officer
• Organization: Soligenix, Inc.

rstraube@soligenix.com

609-538-8200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: December 5, 2023
• Primary Completion: May 31, 2024
• Study Completion: June 27, 2024
• Last Updated: August 20, 2025
• Results First Posted: August 20, 2025

Record last verified: 2025-08

Locations

US (1)