Trial Outcomes & Findings for Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis (NCT NCT00954915)
NCT ID: NCT00954915
Last Updated: 2022-02-10
Results Overview
Primary endpoints include safety data such as vital signs, physical examinations, electrocardiograms, AE reports, and laboratory test results.
TERMINATED
PHASE1/PHASE2
1 participants
Day 0 through Day 84
2022-02-10
Participant Flow
Recruitment began at two academic institutions in April 2010 and was halted on December 17, 2010 after the first subject had an injection site reaction that met study stopping criteria.
Participant milestones
| Measure |
Teplizumab
Anti CD-3 monoclonal antibody
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis
Baseline characteristics by cohort
| Measure |
Teplizumab
n=1 Participants
Anti CD-3 monoclonal antibody
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 through Day 84Population: One subject was enrolled and followed per protocol. This subject's data are described in the adverse events summary.
Primary endpoints include safety data such as vital signs, physical examinations, electrocardiograms, AE reports, and laboratory test results.
Outcome measures
| Measure |
Teplizumab
n=1 Participants
anti-CD3 monoclonal antibody
|
|---|---|
|
Adverse Events (AE)
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 0, 14, 28, 63 and 84Population: Data were not collected due to early termination of the study.
The LS-PGA score is determined by estimating the extent of body surface area involved by psoriasis and rating plaque qualities (elevation, erythema, scaling) averaged over the entire body. LS-PGA score is then determined using available software. LS-PGA ranks involvement on an 8 point scale from clear, almost clear, mild, mild to moderate, moderate, moderate to severe, severe, and very severe. Participants who have an improvement of one or more steps in the LS-PGA will be considered to have met the primary criteria for a clinical response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0, 14, 28, 63 and 84Population: Data were not collected due to early termination of the study.
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of plaque scale, erythema, and plaque induration (thickness) in each region, yielding an overall score of 0 for no psoriasis to a maximum of 72 for severe disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0, 14, 28, 63 and 84Population: Data were not collected due to early termination of the study.
The PGA rates the subject's psoriasis relative to baseline as 1 (100% clearing), 2 (excellent: 75% through 99% clearing with striking improvement), 3 (good: 50% through 74% clearing with moderate improvement), 4 (fair: 25% through 49% clearing with slight improvement), 5 (poor: 0% through 24% clearing with little or no change), or 6 (worsening). Involvement of body-surface area, induration, scaling, and erythema are taken into account.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 through Day 84Population: Data were not collected due to early termination of the study.
Outcome measures
Outcome data not reported
Adverse Events
Teplizumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Teplizumab
n=1 participants at risk
Anti CD-3 monoclonal antibody
|
|---|---|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
100.0%
1/1 • Number of events 1
|
|
Investigations
C-reactive protein increased
|
100.0%
1/1 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Injection site reaction condition aggravated
|
100.0%
1/1 • Number of events 1
|
|
General disorders
Pyrexia
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 1
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypotension
|
100.0%
1/1 • Number of events 1
|
|
Investigations
Neutrophil count increased
|
100.0%
1/1 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 1
|
|
Investigations
CD3 lymphocytes decreased
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelet count increased
|
100.0%
1/1 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
100.0%
1/1 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60