Trial Outcomes & Findings for FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) (NCT NCT02448381)

Last Updated: 2022-04-15

Results Overview

The percentage of patients achieving a treatment response in each of the 2 treatment groups. A treatment response was defined as a ≥50% improvement in CAILS score at Week 8 when compared to the CAILS score at baseline. The Composite Assessment of Index Lesion Disease Severity (CAILS) 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. The overall CAILS score was calculated by adding the total score as described above for each of the 3 lesions. The overall CAILS score has a range of 0 to 111. A lower score means a better outcome.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

169 participants

Primary outcome timeframe

8 weeks

Results posted on

2022-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	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). 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.	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. Placebo: USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 18-24 hours, then treated with an initial dose of 12 J/cm\^2 fluorescent light.
Overall Study STARTED	118	51
Overall Study Randomized, Not Treated	2	1
Overall Study Cycle 1	116	50
Overall Study Cycle 2	110	45
Overall Study Cycle 3	78	32
Overall Study Follow-up Period	98	39
Overall Study COMPLETED	83	32
Overall Study NOT COMPLETED	35	19

Reasons for withdrawal

Reasons for withdrawal
Measure	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). 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.	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. Placebo: USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 18-24 hours, then treated with an initial dose of 12 J/cm\^2 fluorescent light.
Overall Study Adverse Event	2	0
Overall Study Lost to Follow-up	16	9
Overall Study Physician Decision	1	1
Overall Study Pregnancy	1	0
Overall Study Withdrawal by Subject	13	9
Overall Study Noncompliance with Study Procedures	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SGX301 n=116 Participants 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). 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.	Placebo n=50 Participants 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. 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.	Total n=166 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 15.94 • n=5 Participants	59.4 years STANDARD_DEVIATION 16.26 • n=7 Participants	58.4 years STANDARD_DEVIATION 16.00 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	23 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants	27 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	103 Participants n=5 Participants	45 Participants n=7 Participants	148 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized White	84 Participants n=5 Participants	36 Participants n=7 Participants	120 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	27 Participants n=5 Participants	12 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301 or Placebo)

Outcome measures

Outcome measures
Measure	SGX301 n=116 Participants 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 have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin 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.	Placebo n=50 Participants 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. Cycle 1: Patients have three (3) index lesions treated with 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.
Number of Responders and Non-Responders With a 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 Responder	19 Participants	2 Participants
Number of Responders and Non-Responders With a 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 Non-responder	97 Participants	48 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: The analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301) in Cycle 2

The percentage of patients achieving a treatment response at Week 16 that received SGX301 for both Cycle 1 and 2 compared to the response rate in patients that received Placebo in Cycle 1. The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.

Outcome measures

Outcome measures
Measure	SGX301 n=110 Participants 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 have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin 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.	Placebo n=50 Participants 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. Cycle 1: Patients have three (3) index lesions treated with 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.
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo) Responder	44 Participants	2 Participants
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo) Non-responder	66 Participants	48 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: The analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301) in Cycle 2

The percentage of patients achieving a treatment response at Week 24 compared at Week 16 in SGX301 treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline. The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.

Outcome measures

Outcome measures
Measure	SGX301 n=78 Participants 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 have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin 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.	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. Cycle 1: Patients have three (3) index lesions treated with 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.
Number of Responders and Non-Responders With a Treatment Response of 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score in Patients Who Received 3 Cycles of SGX301 Responder	38 Participants	—
Number of Responders and Non-Responders With a Treatment Response of 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score in Patients Who Received 3 Cycles of SGX301 Non-responder	40 Participants	—

SECONDARY outcome

Timeframe: 16 weeks

Population: The analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301) in Cycle 2

The proportion of patch lesions achieving a treatment response at Week 16 in the SGX301 treatment group compared to Week 8 in the Placebo treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline for individual lesions. The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.

Outcome measures

Outcome measures
Measure	SGX301 n=178 lesions 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 have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin 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.	Placebo n=85 lesions 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. Cycle 1: Patients have three (3) index lesions treated with 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.
Patch Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)	65 lesions with response	14 lesions with response

SECONDARY outcome

Timeframe: 16 weeks

Population: The analysis population was defined as all lesions that were treated with at least one dose of treatment (SGX301) in Cycle 2

The proportion of plaque lesions achieving a treatment response at Week 16 in the SGX301 treatment group compared to Week 8 in the Placebo treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline for individual lesions. The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.

Outcome measures

Outcome measures
Measure	SGX301 n=152 lesions 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 have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin 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.	Placebo n=65 lesions 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. Cycle 1: Patients have three (3) index lesions treated with 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.
Plaque Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)	64 lesions with response	7 lesions with response

Adverse Events

Cycle 1 - SGX301

Serious events: 1 serious events

Other events: 56 other events

Deaths: 0 deaths

Cycle 1 - Placebo

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Cycle 2 - SGX301

Serious events: 0 serious events

Other events: 66 other events

Deaths: 0 deaths

Cycle 3 - SGX301

Serious events: 3 serious events

Other events: 49 other events

Deaths: 0 deaths

Overall SGX301

Serious events: 4 serious events

Other events: 108 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cycle 1 - SGX301 n=116 participants at risk Patients treated with SGX301 in Cycle 1.	Cycle 1 - Placebo n=50 participants at risk Patients treated with Placebo in Cycle 1. Cycle 1 is the only cycle that used Placebo.	Cycle 2 - SGX301 n=155 participants at risk Patients treated with SGX301 in Cycle 2. Since all patients received SGX301 in Cycle 2, this includes 45 patients that received Placebo in Cycle 1 and 110 patients that continued to receive SGX301 in Cycle 2.	Cycle 3 - SGX301 n=110 participants at risk Patients treated with SGX301 in Cycle 3. Since all patients received SGX301 in Cycle 3, this includes 32 patients that received Placebo in Cycle 1 and 78 patients that continued to receive SGX301 in Cycle 3.	Overall SGX301 n=161 participants at risk Any participant that received at least one dose of SGX301 during any cycle of the trial.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	2.0% 1/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Hepatobiliary disorders Gallbladder obstruction	0.00% 0/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.91% 1/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.62% 1/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Gastrointestinal disorders Gastritis alcoholic	0.86% 1/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.62% 1/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Hepatobiliary disorders Cholecystitis	0.00% 0/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.91% 1/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.62% 1/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Infections and infestations Pneumonia	0.00% 0/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.91% 1/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.62% 1/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)

Other adverse events

Other adverse events
Measure	Cycle 1 - SGX301 n=116 participants at risk Patients treated with SGX301 in Cycle 1.	Cycle 1 - Placebo n=50 participants at risk Patients treated with Placebo in Cycle 1. Cycle 1 is the only cycle that used Placebo.	Cycle 2 - SGX301 n=155 participants at risk Patients treated with SGX301 in Cycle 2. Since all patients received SGX301 in Cycle 2, this includes 45 patients that received Placebo in Cycle 1 and 110 patients that continued to receive SGX301 in Cycle 2.	Cycle 3 - SGX301 n=110 participants at risk Patients treated with SGX301 in Cycle 3. Since all patients received SGX301 in Cycle 3, this includes 32 patients that received Placebo in Cycle 1 and 78 patients that continued to receive SGX301 in Cycle 3.	Overall SGX301 n=161 participants at risk Any participant that received at least one dose of SGX301 during any cycle of the trial.
Skin and subcutaneous tissue disorders Pruritus	5.2% 6/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	4.0% 2/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.3% 2/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	4.5% 5/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	7.5% 12/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Skin and subcutaneous tissue disorders Erythema	2.6% 3/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.9% 3/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.91% 1/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	4.3% 7/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Infections and infestations Upper respiratory tract infection	6.9% 8/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	8.0% 4/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.3% 2/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.8% 2/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	7.5% 12/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Infections and infestations Viral upper respiratory tract infection	3.4% 4/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	2.6% 4/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	3.6% 4/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	6.8% 11/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Infections and infestations Sinusitis	0.86% 1/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.9% 3/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	2.7% 3/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	4.3% 7/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Infections and infestations Urinary tract infection	0.86% 1/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	4.0% 2/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.9% 3/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	2.5% 4/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Infections and infestations Influenza	0.00% 0/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	4.0% 2/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.65% 1/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.8% 2/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.9% 3/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
General disorders Application site pain	6.9% 8/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	4.0% 2/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	3.2% 5/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	5.5% 6/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	9.9% 16/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
General disorders Application site pruritus	4.3% 5/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	2.0% 1/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	3.2% 5/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	5.6% 9/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
General disorders Fatigue	2.6% 3/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	2.0% 1/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.9% 3/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.8% 2/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	5.0% 8/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
General disorders Application site paraesthesia	5.2% 6/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.3% 2/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.8% 2/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	4.3% 7/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
General disorders Pain	2.6% 3/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.3% 2/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	3.1% 5/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Gastrointestinal disorders Nausea	2.6% 3/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	2.0% 1/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.3% 2/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.8% 2/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	4.3% 7/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Gastrointestinal disorders Diarrhoea	3.4% 4/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.9% 3/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	3.7% 6/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Nervous system disorders Headache	4.3% 5/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	6.0% 3/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	3.2% 5/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.8% 2/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	6.2% 10/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Nervous system disorders Dizziness	2.6% 3/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	2.0% 1/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.65% 1/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.8% 2/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	3.7% 6/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	7.8% 9/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	2.0% 1/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	3.2% 5/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	4.5% 5/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	10.6% 17/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	5.2% 6/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	4.0% 2/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	2.6% 4/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	4.5% 5/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	8.7% 14/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	2.6% 3/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	6.0% 3/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	3.9% 6/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	3.6% 4/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	6.8% 11/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0.00% 0/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	2.0% 1/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.9% 3/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.8% 2/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	3.1% 5/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)
Eye disorders Eye disorders	2.6% 3/116 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/50 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	1.3% 2/155 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	0.00% 0/110 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)	3.1% 5/161 • From the first dose of study drug (SGX301 or Placebo) until 1 month following the participant's last evaluation visit (Cycle 1 = 8 weeks, Cycle 2 = 16 weeks, Cycle 3 = 24 weeks)

Additional Information

Richard Straube, MD/Chief Medical Officer

Soligenix, Inc.

Phone: 609-538-8200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place