Trial Outcomes & Findings for An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease (NCT NCT01009281)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

From Start of the Study up to Study Termination (up to 42 Weeks)

Results posted on

2021-07-12

Participant Flow

The study was conducted at 6 centers in 3 countries USA, Canada, Poland between 30-August-2009 (first participant enrolled) to 19-August-2010 (Last participant completed).

A total of 7 participants enrolled in the study. All seven participants were discontinued due to early termination of the core study (CAIN457A2202 \[NCT00584740\]) due to lack of efficacy.

Participant milestones

Participant milestones
Measure	Secukinumab Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Overall Study STARTED	7
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Secukinumab Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Overall Study Administrative problems	7

Baseline Characteristics

An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Secukinumab n=7 Participants Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Age, Continuous	44.9 Years STANDARD_DEVIATION 15.79 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Start of the Study up to Study Termination (up to 42 Weeks)

Population: Safety analysis set consisted of all participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Secukinumab n=7 Participants Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Number of Participants With Adverse Events	3 Participants

SECONDARY outcome

Timeframe: From Start of the Study up to Study Termination (up to 42 Weeks)

Population: Safety analysis set consisted of all participants who received at least one dose of study drug.

Anti-AIN457 antibodies were assessed in serum.

Outcome measures

Outcome measures
Measure	Secukinumab n=7 Participants Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Number of Participants With Anti-AIN457 Antibodies	NA Participants Due to significant delays in sample processing this analysis was not conducted, hence results are not available.

SECONDARY outcome

Timeframe: Baseline up to Study Termination (up to 42 Weeks)

Population: Safety analysis set consisted of all participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Secukinumab n=7 Participants Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Change From Baseline in Concentration of Interleukin 17 (IL-17)	NA Participants Due to technical issues this analysis could not be conducted and therefore no results are available for inclusion in this report.

SECONDARY outcome

Timeframe: Baseline up to Study Termination (up to 42 Weeks)

Population: Safety analysis set consisted of all participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Secukinumab n=7 Participants Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin	NA Participants Results are unavailable as the analysis could not be performed due to early termination and the small number of participants in the study

SECONDARY outcome

Timeframe: Baseline up to Study Termination (up to 42 Weeks)

Population: Safety analysis set consisted of all participants who received at least one dose of study drug. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Secukinumab n=6 Participants Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Change From Baseline in C-Reactive Protein Levels	14.2 milligram per liter (mg/L) Standard Deviation 20.54

SECONDARY outcome

Timeframe: Pre-dose, post dose on week 44 (end of infusion)

Population: Pharmacokinetic data analysis included all participants with evaluable pharmacokinetic data. Due to the early discontinuation of all participants, the full dataset of concentration measurements could not be obtained, analyzed and reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, post dose on week 44 (end of infusion)

Population: Pharmacokinetic data analysis included all participants with evaluable pharmacokinetic data. Due to the early discontinuation of all participants, the full dataset of concentration measurements could not be obtained, analyzed and reported.

Outcome measures

Outcome data not reported

Adverse Events

Secukinumab

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Secukinumab n=7 participants at risk Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Gastrointestinal disorders Abdominal distension	14.3% 1/7 • From Start of the Study up to Study Termination (up to 42 weeks)
Gastrointestinal disorders Gastrooesophageal reflux disease	14.3% 1/7 • From Start of the Study up to Study Termination (up to 42 weeks)
Gastrointestinal disorders Nausea	14.3% 1/7 • From Start of the Study up to Study Termination (up to 42 weeks)
Gastrointestinal disorders Vomiting	14.3% 1/7 • From Start of the Study up to Study Termination (up to 42 weeks)
General disorders Influenza like illness	14.3% 1/7 • From Start of the Study up to Study Termination (up to 42 weeks)
Infections and infestations Upper respiratory tract infection	14.3% 1/7 • From Start of the Study up to Study Termination (up to 42 weeks)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	14.3% 1/7 • From Start of the Study up to Study Termination (up to 42 weeks)
Psychiatric disorders Depression	14.3% 1/7 • From Start of the Study up to Study Termination (up to 42 weeks)

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place