Trial Outcomes & Findings for A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD) (NCT NCT04237116)
NCT ID: NCT04237116
Last Updated: 2024-02-29
Results Overview
Psoriasis Area and Severity Index (PASI) 90 response is defined as ≥ 90% improvement (reduction) in score compared to Baseline. It is a composite score where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. Score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Primary analysis was planned to be performed comparing treatments with respect to the primary efficacy variable in a logistic regression model.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
10 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-02-29
Participant Flow
7 German centers and 1 Spanish center had randomized 8 and 2 patients, respectively. Patients who were still in the study when the sponsor terminated the study were counted as 'non-completers'.
This study was prematurely discontinued after the enrollment of 10 patients, because the recruitment was too slow to achieve the planned number of patients within a reasonable time frame. No safety issues led to the decision to terminate the study prematurely.
Participant milestones
| Measure |
Investigational Arm - Secukinumab
secukinumab 300mg s.c. weekly in first 4 weeks, followed by q4w up to Week 20; and placebo 300mg s.c. at weeks 13, 14 and 15 to maintain the blind
|
Control Arm - Placebo
placebo 300 mg s.c. weekly in first 4 weeks, followed by q4w up to Week 8; and secukinumab 300 mg s.c. weekly for 4 weeks starting at Week 12, followed by q4w up to Week 20
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Investigational Arm - Secukinumab
secukinumab 300mg s.c. weekly in first 4 weeks, followed by q4w up to Week 20; and placebo 300mg s.c. at weeks 13, 14 and 15 to maintain the blind
|
Control Arm - Placebo
placebo 300 mg s.c. weekly in first 4 weeks, followed by q4w up to Week 8; and secukinumab 300 mg s.c. weekly for 4 weeks starting at Week 12, followed by q4w up to Week 20
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Study terminated by Sponsor
|
4
|
1
|
Baseline Characteristics
A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD)
Baseline characteristics by cohort
| Measure |
Investigational Arm - Secukinumab
n=7 Participants
secukinumab 300mg s.c. weekly in first 4 weeks, followed by q4w up to Week 20; and placebo 300mg s.c. at weeks 13, 14 and 15 to maintain the blind
|
Control Arm - Placebo
n=3 Participants
placebo 300 mg s.c. weekly in first 4 weeks, followed by q4w up to Week 8; and secukinumab 300 mg s.c. weekly for 4 weeks starting at Week 12, followed by q4w up to Week 20
|
Total
n=10 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
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
32.0 years
STANDARD_DEVIATION 16.8 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set (FAS): Comprised all patients to whom study treatment/reference treatment had been assigned by randomization.
Psoriasis Area and Severity Index (PASI) 90 response is defined as ≥ 90% improvement (reduction) in score compared to Baseline. It is a composite score where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. Score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Primary analysis was planned to be performed comparing treatments with respect to the primary efficacy variable in a logistic regression model.
Outcome measures
| Measure |
Investigational Arm - Secukinumab
n=7 Participants
secukinumab 300mg s.c. weekly in first 4 weeks, followed by q4w up to Week 20; and placebo 300mg s.c. at weeks 13, 14 and 15 to maintain the blind
|
Control Arm - Placebo
n=3 Participants
placebo 300 mg s.c. weekly in first 4 weeks, followed by q4w up to Week 8; and secukinumab 300 mg s.c. weekly for 4 weeks starting at Week 12, followed by q4w up to Week 20
|
|---|---|---|
|
Mean and SD Change From Baseline of PASI Score up to Week 12
Baseline (n=7,3)
|
15.7 Units on a scale
Standard Deviation 4.22
|
15.9 Units on a scale
Standard Deviation 3.39
|
|
Mean and SD Change From Baseline of PASI Score up to Week 12
Week 12 (n=4,2)
|
0.8 Units on a scale
Standard Deviation 1.14
|
13.4 Units on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: FAS
ALT is an enzyme that the liver releases when it becomes inflamed or damaged. ALT level measures liver function Parameter. Normal range of values for ALT is about 7 to 56 units per liter (U/L). Higher levels of ALT in the blood indicate more liver problems. Due to the premature study termination and the limited number of treated patients with available data (7 patients in the secukinumab group and 3 patients in the placebo group), the extent of the originally planned statistical analyses of efficacy data was limited to descriptive summaries (absolute values per visit and changes from baseline; presented as mean and standard deviation) for the ALT score.
Outcome measures
| Measure |
Investigational Arm - Secukinumab
n=7 Participants
secukinumab 300mg s.c. weekly in first 4 weeks, followed by q4w up to Week 20; and placebo 300mg s.c. at weeks 13, 14 and 15 to maintain the blind
|
Control Arm - Placebo
n=3 Participants
placebo 300 mg s.c. weekly in first 4 weeks, followed by q4w up to Week 8; and secukinumab 300 mg s.c. weekly for 4 weeks starting at Week 12, followed by q4w up to Week 20
|
|---|---|---|
|
Serum Alanine Aminotransferase (ALT) Level
Baseline
|
60.5 U/L
Standard Deviation 35.73
|
89.0 U/L
Standard Deviation 15.56
|
|
Serum Alanine Aminotransferase (ALT) Level
Week 12
|
43.3 U/L
Standard Deviation 12.76
|
85.5 U/L
Standard Deviation 20.51
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: FAS
Dermatology Life Quality Index (DLQI) is calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life. Due to the premature study termination and the limited number of treated patients with available data (7 patients in the secukinumab group and 3 patients in the placebo group), the extent of the originally planned statistical analyses of efficacy data was limited to descriptive summaries (absolute values per visit and changes from baseline; presented as mean and standard deviation) for DLQI scores.
Outcome measures
| Measure |
Investigational Arm - Secukinumab
n=7 Participants
secukinumab 300mg s.c. weekly in first 4 weeks, followed by q4w up to Week 20; and placebo 300mg s.c. at weeks 13, 14 and 15 to maintain the blind
|
Control Arm - Placebo
n=3 Participants
placebo 300 mg s.c. weekly in first 4 weeks, followed by q4w up to Week 8; and secukinumab 300 mg s.c. weekly for 4 weeks starting at Week 12, followed by q4w up to Week 20
|
|---|---|---|
|
Mean and SD of DLQI at Week 12
Baseline
|
11.3 Units on a scale
Standard Deviation 5.56
|
8.0 Units on a scale
Standard Deviation 8.49
|
|
Mean and SD of DLQI at Week 12
Week 12
|
0.3 Units on a scale
Standard Deviation 0.50
|
7.0 Units on a scale
Standard Deviation 8.49
|
Adverse Events
Secukinumab 300mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secukinumab 300mg
n=7 participants at risk
Secukinumab 300mg
|
Placebo
n=3 participants at risk
Placebo
|
|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
Other adverse events
| Measure |
Secukinumab 300mg
n=7 participants at risk
Secukinumab 300mg
|
Placebo
n=3 participants at risk
Placebo
|
|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
28.6%
2/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Infections and infestations
Oral herpes
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Investigations
Low density lipoprotein increased
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Investigations
Urinary sediment abnormal
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Investigations
Urine analysis abnormal
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 24 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER