Trial Outcomes & Findings for Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis (NCT NCT02764229)

Last Updated: 2019-03-27

Results Overview

Adverse events (AEs) were collected from the time a subject signed the informed consent and completed participation in the preceding double-blind trial LYC-30937-2001. Treatment-emergent adverse events (TEAEs) are AEs occurring or worsening after the first dose of study drug (LYC-30937-EC 25 mg). Adverse event severity was assessed by the Investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03, with grading as follows: Grade 1 = mild (asymptomatic or mild symptoms), Grade 2 = moderate (minimal, local intervention, or noninvasive intervention indicated); Grade 3 = severe (or medically significant but not life-threatening); Grade 4 = life-threatening; Grade 5 = death.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

112 participants

Primary outcome timeframe

46 weeks

Results posted on

2019-03-27

Participant Flow

Participants were enrolled at 40 study centers with the United States, Poland, Hungary, Czech Republic, Serbia and Netherlands. Study centers included academic medical centers and non-academic medical clinics.

Eligible subjects were those completing the preceding double-blind study LYC-30937-2001 Week 8 visit.

Participant milestones

Participant milestones
Measure	LYC-30937-EC LYC-30937-EC 25 mg by mouth once daily
Overall Study STARTED	112
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	102

Reasons for withdrawal

Reasons for withdrawal
Measure	LYC-30937-EC LYC-30937-EC 25 mg by mouth once daily
Overall Study Withdrawal by Subject	15
Overall Study Adverse Event	9
Overall Study Physician Decision	5
Overall Study Lost to Follow-up	3
Overall Study Lack of Efficacy	1
Overall Study Study Stopped by Sponsor	69

Baseline Characteristics

Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LYC-30937-EC n=112 Participants LYC-30937-EC 25 mg by mouth once daily
Age, Continuous	41.5 years n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	109 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Netherlands	3 subjects n=5 Participants
Region of Enrollment Hungary	2 subjects n=5 Participants
Region of Enrollment United States	22 subjects n=5 Participants
Region of Enrollment Czechia	4 subjects n=5 Participants
Region of Enrollment Poland	76 subjects n=5 Participants
Region of Enrollment Serbia	5 subjects n=5 Participants

PRIMARY outcome

Timeframe: 46 weeks

Population: Safety Set, consisting of all subjects who took at least 1 dose of study drug. 112 subjects signed consent to participate in the study and 111 of these were confirmed to have taken at least 1 dose of study drug. (One subject was lost to follow-up after enrolling and it was not confirmed that they took study drug.)

Outcome measures

Outcome measures
Measure	LYC-30937-EC n=111 Participants LYC-30937-EC 25 mg by mouth once daily
Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment Subjects with ≥ 1 AE	56 Participants
Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment Subjects with ≥ 1 SAE	6 Participants
Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment Subjects with AE leading to discontinuation	9 Participants

Adverse Events

LYC-30937-EC

Serious events: 6 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LYC-30937-EC n=111 participants at risk LYC-30937-EC 25 mg by mouth once daily
Gastrointestinal disorders Ulcerative colitis	1.8% 2/111 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent through their last study visit, up to 46 weeks. Adverse events occurring after the first dose of study drug (treatment-emergent adverse events) are reported in this section.
Gastrointestinal disorders Pancreatitis acute	0.90% 1/111 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent through their last study visit, up to 46 weeks. Adverse events occurring after the first dose of study drug (treatment-emergent adverse events) are reported in this section.
Infections and infestations Anal abscess	0.90% 1/111 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent through their last study visit, up to 46 weeks. Adverse events occurring after the first dose of study drug (treatment-emergent adverse events) are reported in this section.
Blood and lymphatic system disorders Anaemia	0.90% 1/111 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent through their last study visit, up to 46 weeks. Adverse events occurring after the first dose of study drug (treatment-emergent adverse events) are reported in this section.
Respiratory, thoracic and mediastinal disorders Chronic obstructuve pulmonary disease	0.90% 1/111 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent through their last study visit, up to 46 weeks. Adverse events occurring after the first dose of study drug (treatment-emergent adverse events) are reported in this section.
Infections and infestations Pneumonia	0.90% 1/111 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent through their last study visit, up to 46 weeks. Adverse events occurring after the first dose of study drug (treatment-emergent adverse events) are reported in this section.

Other adverse events

Other adverse events
Measure	LYC-30937-EC n=111 participants at risk LYC-30937-EC 25 mg by mouth once daily
Gastrointestinal disorders Colitis ulcerative	9.9% 11/111 • Number of events 15 • Adverse events were collected from the time the subject signed informed consent through their last study visit, up to 46 weeks. Adverse events occurring after the first dose of study drug (treatment-emergent adverse events) are reported in this section.
Blood and lymphatic system disorders Anaemia	6.3% 7/111 • Number of events 9 • Adverse events were collected from the time the subject signed informed consent through their last study visit, up to 46 weeks. Adverse events occurring after the first dose of study drug (treatment-emergent adverse events) are reported in this section.

Additional Information

H. Jeffrey Wilkins MD, Chief Medical Officer

Lycera Corp.

Phone: 484-243-6222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Center results cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then Investigator can publish if manuscript is submitted to Lycera ≥ 60 days prior to submission (or per Investigator contract). If Lycera decides publication would hinder development, Investigator must delay submission. Investigator must delete confidential information before submission and defer publication to allow patent applications.
Publication restrictions are in place

Restriction type: OTHER