Trial Outcomes & Findings for IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo (NCT NCT04190693)
NCT ID: NCT04190693
Last Updated: 2022-05-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Throughout the study period (24weeks)
Results posted on
2022-05-02
Participant Flow
Participant milestones
| Measure |
Cohort 1
Patients having received 50 μg IMP (2x subcutaneous \[s.c.\] injections of 25 μg \[100 μL each\]) + 3x 25 μg IMP (each as 2x s.c. injections of 12.5 μg \[50 μL each\]) in study 2016-003514-27
|
Cohort 2
Patients having received 150 μg IMP (2x s.c. injections of 75 μg \[300 μL each\]) + 3x 75 μg IMP (each as 2x s.c injections of 12.5 μg \[150 μL each\]) in study 2016-003514-27
|
Cohort 3
Patients having received 450 μg IMP (2x s.c. injections of 225 μg \[900 μL each\]) + 3x 225 μg IMP (each as 2x s.c injections of 112.5 μg \[450 μL each\]) in study 2016-003514-27
|
Placebo
Patients having received Placebo in study 2016-003514-27
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
12
|
7
|
|
Overall Study
COMPLETED
|
4
|
7
|
12
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=4 Participants
Patients having received 50 μg IMP (2x subcutaneous \[s.c.\] injections of 25 μg \[100 μL each\]) + 3x 25 μg IMP (each as 2x s.c. injections of 12.5 μg \[50 μL each\]) in study 2016-003514-27
|
Cohort 2
n=7 Participants
Patients having received 150 μg IMP (2x s.c. injections of 75 μg \[300 μL each\]) + 3x 75 μg IMP (each as 2x s.c injections of 12.5 μg \[150 μL each\]) in study 2016-003514-27
|
Cohort 3
n=12 Participants
Patients having received 450 μg IMP (2x s.c. injections of 225 μg \[900 μL each\]) + 3x 225 μg IMP (each as 2x s.c injections of 112.5 μg \[450 μL each\]) in study 2016-003514-27
|
Placebo
n=7 Participants
Patients having received Placebo in study 2016-003514-27
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=4 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=12 Participants
|
7 Participants
n=7 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
25.0 years
STANDARD_DEVIATION 2.7 • n=4 Participants
|
26.1 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
25.1 years
STANDARD_DEVIATION 4.8 • n=12 Participants
|
26.0 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
25.5 years
STANDARD_DEVIATION 4.1 • n=30 Participants
|
|
Sex: Female, Male
Gender categorical · Female
|
1 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=30 Participants
|
|
Sex: Female, Male
Gender categorical · Male
|
3 Participants
n=4 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=12 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Throughout the study period (24weeks)Outcome measures
| Measure |
Cohort 1
n=4 Participants
Patients having received 50 μg IMP (2x subcutaneous \[s.c.\] injections of 25 μg \[100 μL each\]) + 3x 25 μg IMP (each as 2x s.c. injections of 12.5 μg \[50 μL each\]) in study 2016-003514-27
|
Cohort 2
n=7 Participants
Patients having received 150 μg IMP (2x s.c. injections of 75 μg \[300 μL each\]) + 3x 75 μg IMP (each as 2x s.c injections of 12.5 μg \[150 μL each\]) in study 2016-003514-27
|
Cohort 3
n=12 Participants
Patients having received 450 μg IMP (2x s.c. injections of 225 μg \[900 μL each\]) + 3x 225 μg IMP (each as 2x s.c injections of 112.5 μg \[450 μL each\]) in study 2016-003514-27
|
Placebo
n=7 Participants
Patients having received Placebo in study 2016-003514-27
|
|---|---|---|---|---|
|
Adverse Events
|
5 Number of AE
|
6 Number of AE
|
10 Number of AE
|
4 Number of AE
|
PRIMARY outcome
Timeframe: Throughout the study period (24 weeks)Outcome measures
| Measure |
Cohort 1
n=4 Participants
Patients having received 50 μg IMP (2x subcutaneous \[s.c.\] injections of 25 μg \[100 μL each\]) + 3x 25 μg IMP (each as 2x s.c. injections of 12.5 μg \[50 μL each\]) in study 2016-003514-27
|
Cohort 2
n=7 Participants
Patients having received 150 μg IMP (2x s.c. injections of 75 μg \[300 μL each\]) + 3x 75 μg IMP (each as 2x s.c injections of 12.5 μg \[150 μL each\]) in study 2016-003514-27
|
Cohort 3
n=12 Participants
Patients having received 450 μg IMP (2x s.c. injections of 225 μg \[900 μL each\]) + 3x 225 μg IMP (each as 2x s.c injections of 112.5 μg \[450 μL each\]) in study 2016-003514-27
|
Placebo
n=7 Participants
Patients having received Placebo in study 2016-003514-27
|
|---|---|---|---|---|
|
Serious Adverse Events
|
0 Number of SAE
|
0 Number of SAE
|
0 Number of SAE
|
0 Number of SAE
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=4 participants at risk
Patients having received 50 μg IMP (2x subcutaneous \[s.c.\] injections of 25 μg \[100 μL each\]) + 3x 25 μg IMP (each as 2x s.c. injections of 12.5 μg \[50 μL each\]) in study 2016-003514-27
|
Cohort 2
n=7 participants at risk
Patients having received 150 μg IMP (2x s.c. injections of 75 μg \[300 μL each\]) + 3x 75 μg IMP (each as 2x s.c injections of 12.5 μg \[150 μL each\]) in study 2016-003514-27
|
Cohort 3
n=12 participants at risk
Patients having received 450 μg IMP (2x s.c. injections of 225 μg \[900 μL each\]) + 3x 225 μg IMP (each as 2x s.c injections of 112.5 μg \[450 μL each\]) in study 2016-003514-27
|
Placebo
n=7 participants at risk
Patients having received Placebo in study 2016-003514-27
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
8.3%
1/12 • Number of events 1 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
Injury, poisoning and procedural complications
Sports injury
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
8.3%
1/12 • Number of events 1 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
28.6%
2/7 • Number of events 2 • Throughout the study period (24 weeks)
|
0.00%
0/12 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
8.3%
1/12 • Number of events 1 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
0.00%
0/12 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
8.3%
1/12 • Number of events 1 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
Gastrointestinal disorders
Adbominal pain upper
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
8.3%
1/12 • Number of events 1 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
14.3%
1/7 • Number of events 1 • Throughout the study period (24 weeks)
|
0.00%
0/12 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
0.00%
0/12 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
0.00%
0/12 • Throughout the study period (24 weeks)
|
14.3%
1/7 • Number of events 1 • Throughout the study period (24 weeks)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
0.00%
0/12 • Throughout the study period (24 weeks)
|
14.3%
1/7 • Number of events 1 • Throughout the study period (24 weeks)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
8.3%
1/12 • Number of events 1 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
0.00%
0/12 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
16.7%
2/12 • Number of events 3 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
0.00%
0/12 • Throughout the study period (24 weeks)
|
14.3%
1/7 • Number of events 1 • Throughout the study period (24 weeks)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
28.6%
2/7 • Number of events 2 • Throughout the study period (24 weeks)
|
0.00%
0/12 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
8.3%
1/12 • Number of events 1 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
0.00%
0/12 • Throughout the study period (24 weeks)
|
14.3%
1/7 • Number of events 1 • Throughout the study period (24 weeks)
|
|
Infections and infestations
Fungal ski infection
|
0.00%
0/4 • Throughout the study period (24 weeks)
|
14.3%
1/7 • Number of events 1 • Throughout the study period (24 weeks)
|
0.00%
0/12 • Throughout the study period (24 weeks)
|
0.00%
0/7 • Throughout the study period (24 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place