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FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

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ClinicalTrials.gov Identifier: NCT02448381
Recruitment Status : Recruiting
First Posted : May 19, 2015
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Soligenix

Brief Summary:
To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Condition or disease Intervention/treatment Phase
Cutaneous T-Cell Lymphoma Drug: SGX301 (synthetic hypericin) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma
Actual Study Start Date : December 2015
Estimated Primary Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: SGX301

Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.

Cycle 1: Patients randomized 2:1 to active/placebo will have three (3) index lesions treated and evaluated.

Cycle 2: All patients will have three (3) index lesions treated and evaluated with active SGX301 ointment.

Cycle 3: All patients will be given the opportunity to enter an open-label cycle of active SGX301 ointment treatment for all lesions (index and non-index).

Drug: SGX301 (synthetic hypericin)
0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.
Other Names:
  • Hypericin
  • Synthetic Hypericin

Placebo Comparator: Placebo
Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.
Drug: Placebo
USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.




Primary Outcome Measures :
  1. Treatment Response in 3 treated lesions as defined as a ≥50% improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) score when compared to patients receiving placebo [ Time Frame: 8 weeks ]
    To evaluate the ability of a 6-week course of SGX301 and visible light in patients with patch/plaque phase cutaneous T-cell lymphoma (CTCL, mycosis fungoides) to induce a treatment response in 3 lesions when compared to patients receiving placebo and visible light.


Secondary Outcome Measures :
  1. Complete Response in 3 treated lesions as defined to be a Composite Assessment of Index Lesion Disease Severity (CAILS) score of 0 [ Time Frame: 8 weeks ]
    To evaluate the ability of topical SGX301 and visible light in patients with patch/plaque phase CTCL to induce biopsy-proven Complete Response.

  2. Degree of Improvement of 3 treated lesions as measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) score [ Time Frame: 16 weeks ]
    To evaluate the degree of improvement of the lesions induced by topical SGX301 and visible light in patients with patch/plaque phase CTCL.

  3. Duration of Response as measured monthly for 6 months by the appearance of new lesions after the treatment period has ended [ Time Frame: 24 weeks ]
    To evaluate the duration of Partial and/or Complete Response in the lesions induced by topical SGX301 and visible light in patients with patch/plaque phase CTCL.

  4. Time to Relapse as measured by any disease recurrence in participants with a Complete Response [ Time Frame: 24 weeks ]
    To evaluate the time to lesion relapse induced by topical SGX301 and visible light in patients with patch/plaque phase CTCL.

  5. Safety as assessed by the number of participants with Adverse Events [ Time Frame: 24 weeks ]
    To assess the safety of topical SGX301 and visible light in patients with patch/plaque phase CTCL.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have a clinical diagnosis of CTCL (mycosis fungoides), Stage IA, Stage IB, or Stage IIA.
  • Subjects must have a minimum of three (3) evaluable, discrete lesions.
  • Subjects must be willing to refrain from sunbathing for the duration of the study.

Exclusion Criteria:

  • History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions or radiation therapy within 30 days of enrolling.
  • Pregnancy or mothers who are breast feeding.
  • Males and females not willing to use effective contraception.
  • Unhealed sunburn.
  • Subjects receiving topical steroids or other topical treatments for CTCL within 2 weeks.
  • Subjects receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment.
  • Subjects with significant history of systemic immunosuppression due to drugs or infection with HIV or HTLV 1.
  • Subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448381


Contacts
Contact: Christopher Pullion, DO 609-538-8200 ext 23 cpullion@soligenix.com
Contact: Richard Straube, MD 609-538-8200 ext 30 rstraube@soligenix.com

  Show 35 Study Locations
Sponsors and Collaborators
Soligenix

Additional Information:
Responsible Party: Soligenix
ClinicalTrials.gov Identifier: NCT02448381     History of Changes
Other Study ID Numbers: HPN-CTCL-01
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Keywords provided by Soligenix:
CTCL
Mycosis fungoides
Hypericin
SGX301
MF

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Hypericin
Antidepressive Agents
Psychotropic Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs