Trial Outcomes & Findings for LYT-100 in Patients With BCRL (NCT NCT04243837)

NCT ID: NCT04243837

Last Updated: 2024-04-23

Results Overview

Evaluate the safety and tolerability of LYT-100 as measured by TEAEs

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-04-23

Participant Flow

Participant milestones

Measure	LYT-100 in Patients With BCRL LYT-100 BID for 6 months LYT-100 BCRL: BCRL patients will receive LYT-100 500 mg BIDX3 days followed by LYT-100 750 mg BID for 6 months	Placebo in Patients With BCRL Placebo BID for 6 months Placebo BCRL: BCRL patients will receive Placebo BID for 6 months
Overall Study STARTED	28	22
Overall Study COMPLETED	10	7
Overall Study NOT COMPLETED	18	15

Reasons for withdrawal

Measure	LYT-100 in Patients With BCRL LYT-100 BID for 6 months LYT-100 BCRL: BCRL patients will receive LYT-100 500 mg BIDX3 days followed by LYT-100 750 mg BID for 6 months	Placebo in Patients With BCRL Placebo BID for 6 months Placebo BCRL: BCRL patients will receive Placebo BID for 6 months
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	4	2
Overall Study Covid-19 lock down	1	0
Overall Study Study Terminated by Sponsor	11	12

Baseline Characteristics

LYT-100 in Patients With BCRL

Baseline characteristics by cohort

Measure	LYT-100 in Patients With BCRL n=28 Participants LYT-100 BID for 6 months LYT-100 BCRL: BCRL patients will receive LYT-100 500mg BID x3 days followed by LYT-100 750mg BID for 6 months	Placebo in Patients With BCRL n=22 Participants Placebo BID for 6 months Placebo BCRL: BCRL patients will receive Placebo BID for 6 months	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	22 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	20 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants
Region of Enrollment Australia	19 participants n=5 Participants	13 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Evaluate the safety and tolerability of LYT-100 as measured by TEAEs

Outcome measures

Measure	LYT-100 in Patients With BCRL n=28 Participants LYT-100 BID for 6 months LYT-100 BCRL: BCRL patients will receive LYT-100 BID for 6 months	Placebo in Patients With BCRL n=22 Participants Placebo BID for 6 months Placebo BCRL: BCRL patients will receive Placebo BID for 6 months
Safety and Tolerability: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	22 Participants	13 Participants

Adverse Events

LYT-100 in Patients With BCRL

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo in Patients With BCRL

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	LYT-100 in Patients With BCRL n=28 participants at risk LYT-100 BID for 6 months LYT-100 BCRL: BCRL patients will receive LYT-100 BID for 6 months	Placebo in Patients With BCRL n=22 participants at risk Placebo BID for 6 months Placebo BCRL: BCRL patients will receive Placebo BID for 6 months
Infections and infestations Pyelonephritis	0.00% 0/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	4.5% 1/22 • Number of events 1 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	4.5% 1/22 • Number of events 1 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.

Other adverse events

Measure	LYT-100 in Patients With BCRL n=28 participants at risk LYT-100 BID for 6 months LYT-100 BCRL: BCRL patients will receive LYT-100 BID for 6 months	Placebo in Patients With BCRL n=22 participants at risk Placebo BID for 6 months Placebo BCRL: BCRL patients will receive Placebo BID for 6 months
Gastrointestinal disorders Nausea	46.4% 13/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	9.1% 2/22 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.
Gastrointestinal disorders Diarrhoea	17.9% 5/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	9.1% 2/22 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.
Gastrointestinal disorders Constipation	7.1% 2/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	9.1% 2/22 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.
Gastrointestinal disorders Dyspepsia	14.3% 4/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	0.00% 0/22 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.
Infections and infestations COVID-19	14.3% 4/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	4.5% 1/22 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.
Infections and infestations Urinary Tract Infection	0.00% 0/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	9.1% 2/22 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.
Nervous system disorders Headache	14.3% 4/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	13.6% 3/22 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.
Nervous system disorders Dizziness	0.00% 0/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	9.1% 2/22 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.
General disorders Fatigue	14.3% 4/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	13.6% 3/22 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.
Skin and subcutaneous tissue disorders Rash	7.1% 2/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	9.1% 2/22 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	9.1% 2/22 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.
Psychiatric disorders Insomnia	10.7% 3/28 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.	0.00% 0/22 • 6 months Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.

Additional Information

Director of Clinical Trials

PureTech Health, Inc

Phone: 6034982261

Email: ckorth@puretechhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place