Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne (NCT NCT03497897)
NCT ID: NCT03497897
Last Updated: 2023-08-31
Results Overview
Inflammatory facial lesion count included papules, pustules, and nodules. The natural log transformed inflammatory facial lesion count up to Week 12 was analyzed using a Bayesian mixed effect model for repeated measurements (MMRM). Values estimated from the model at Week 12 are presented in the table. Posterior geometric mean and 90% credible intervals in each group are presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Week 12
Results posted on
2023-08-31
Participant Flow
Participants took part in 18 investigative sites in 6 countries.
There was an initial screening period of up to 4 weeks.
Participant milestones
| Measure |
LYS006 20 mg BID
LYS006, 20 mg, orally, twice daily (BID), for 12 weeks
|
LYS006 2 mg BID
LYS006, 2 mg, orally, BID, for 12 weeks
|
Placebo BID
Matching placebo, orally, BID, for 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
11
|
29
|
|
Overall Study
Completed Treatment Period
|
23
|
9
|
24
|
|
Overall Study
Pharmacodynamic (PD) Analysis Set
|
24
|
11
|
28
|
|
Overall Study
COMPLETED
|
20
|
9
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
6
|
Reasons for withdrawal
| Measure |
LYS006 20 mg BID
LYS006, 20 mg, orally, twice daily (BID), for 12 weeks
|
LYS006 2 mg BID
LYS006, 2 mg, orally, BID, for 12 weeks
|
Placebo BID
Matching placebo, orally, BID, for 12 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Subject/Guardian Decision
|
2
|
1
|
3
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne
Baseline characteristics by cohort
| Measure |
LYS006 20 mg BID
n=26 Participants
LYS006, 20 mg, orally, twice daily (BID), for 12 weeks
|
LYS006 2 mg BID
n=11 Participants
LYS006, 2 mg, orally, BID, for 12 weeks
|
Placebo BID
n=29 Participants
Matching placebo, orally, BID, for 12 weeks
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23.2 years
STANDARD_DEVIATION 6.89 • n=5 Participants
|
24.5 years
STANDARD_DEVIATION 6.23 • n=7 Participants
|
25.0 years
STANDARD_DEVIATION 5.40 • n=5 Participants
|
24.2 years
STANDARD_DEVIATION 6.13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
21 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
45 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Participants in the PD analysis set who had a valid assessment of the outcome measure.
Inflammatory facial lesion count included papules, pustules, and nodules. The natural log transformed inflammatory facial lesion count up to Week 12 was analyzed using a Bayesian mixed effect model for repeated measurements (MMRM). Values estimated from the model at Week 12 are presented in the table. Posterior geometric mean and 90% credible intervals in each group are presented.
Outcome measures
| Measure |
LYS006 20 mg BID
n=21 Participants
LYS006, 20 mg, orally, twice daily (BID), for 12 weeks
|
LYS006 2 mg BID
n=9 Participants
LYS006, 2 mg, orally, BID, for 12 weeks
|
Placebo BID
n=23 Participants
Matching placebo, orally, BID, for 12 weeks
|
|---|---|---|---|
|
Total Inflammatory Lesion Count
|
18.55 lesions
Interval 14.16 to 24.32
|
24.51 lesions
Interval 16.35 to 36.94
|
20.04 lesions
Interval 15.42 to 26.13
|
Adverse Events
LYS006 20 mg BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
LYS006 2 mg BID
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo BID
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Total
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LYS006 20 mg BID
n=26 participants at risk
LYS006, 20 mg, orally, twice daily (BID), for 12 weeks
|
LYS006 2 mg BID
n=11 participants at risk
LYS006, 2 mg, orally, BID, for 12 weeks
|
Placebo BID
n=29 participants at risk
Matching placebo, orally, BID, for 12 weeks
|
Total
n=66 participants at risk
Total
|
|---|---|---|---|---|
|
Investigations
Neutrophil count increased
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
Protein urine present
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.0%
2/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Blood and lymphatic system disorders
Haemoglobinaemia
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Blood and lymphatic system disorders
Polycythaemia
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
9.1%
1/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
18.2%
2/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.0%
2/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.0%
2/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Gastrointestinal disorders
Constipation
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.0%
2/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
9.1%
1/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Gastrointestinal disorders
Flatulence
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
9.1%
1/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
4.5%
3/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
9.1%
1/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
6.9%
2/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
4.5%
3/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
General disorders
Fatigue
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
General disorders
Influenza like illness
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
9.1%
1/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
General disorders
Oedema
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Infections and infestations
Acarodermatitis
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Infections and infestations
Bronchitis
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Infections and infestations
COVID-19
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Infections and infestations
Cystitis
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
9.1%
1/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Infections and infestations
Genital infection fungal
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Infections and infestations
Gingivitis
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Infections and infestations
Nasopharyngitis
|
11.5%
3/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
27.3%
3/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
10.3%
3/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
13.6%
9/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Infections and infestations
Otitis media
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Infections and infestations
Sinusitis
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Infections and infestations
Urethritis
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
18.2%
2/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
6.9%
2/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
6.1%
4/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
Albumin urine present
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
Aspartate aminotransferase increased
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
Bacterial test positive
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
Blood creatine phosphokinase increased
|
7.7%
2/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
9.1%
1/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
10.3%
3/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
9.1%
6/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
Blood creatinine increased
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
Blood urine present
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
Creatinine urine increased
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
Crystal urine present
|
7.7%
2/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
13.8%
4/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
9.1%
6/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
Haematocrit increased
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.0%
2/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
Haemoglobin increased
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
6.9%
2/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.0%
2/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
Lipase increased
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
Urine protein/creatinine ratio increased
|
7.7%
2/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
9.1%
1/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
6.1%
4/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
White blood cell count increased
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Investigations
White blood cells urine positive
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Nervous system disorders
Headache
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
18.2%
2/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
10.3%
3/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
7.6%
5/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
9.1%
1/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
18.2%
2/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.0%
2/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
9.1%
1/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
3.8%
1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
|
Skin and subcutaneous tissue disorders
Urticaria aquagenic
|
0.00%
0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
0.00%
0/11 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
1.5%
1/66 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days
|
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER