Trial Outcomes & Findings for A Study of Ixekizumab in Participants With Plaque Psoriasis (NCT NCT02993471)
NCT ID: NCT02993471
Last Updated: 2019-03-12
Results Overview
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate (Midazolam)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Results posted on
2019-03-12
Participant Flow
Multicenter, open-label, 2-period, fixed-sequence study.
Participant milestones
| Measure |
Drug Cocktail /Drug Cocktail + Ixekizumab
Period 1: Participants received drug cocktail (100 mg Caffeine, 10 mg Warfarin \[plus vitamin K\], 20 mg Omeprazole, 30 mg Dextromethorphan, and 1 mg Midazolam) administered orally on Day 1. Participants resided at the Clinical Research Unit (CRU) until Day 2, and were discharged following collection of 24-hour pharmacokinetics (PK) samples for the determination of plasma concentrations of the cocktail drugs and metabolites.
Period 2: Participants received a 160 mg dose of Ixekizumab during an outpatient visit on Day 1 (3 to 7 days after Day 5 of Period 1) and were admitted to the CRU on Day 7 (±2 days) to receive the drug cocktail on the morning of Day 8 (Week 1). Participants received single 80 mg doses of Ixekizumab at outpatient visits on Day 15 (Week 2), Day 29 (Week 4), Day 43 (Week 6), Day 57 (Week 8), and Day 71 (Week 10). Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg Ixekizumab and the drug cocktail on the following morning (Day 85; Week 12).
|
|---|---|
|
Period 1 (Drug Cocktail)
STARTED
|
28
|
|
Period 1 (Drug Cocktail)
Received at Least 1 Dose of Study Drug
|
28
|
|
Period 1 (Drug Cocktail)
COMPLETED
|
28
|
|
Period 1 (Drug Cocktail)
NOT COMPLETED
|
0
|
|
Period 2 (Drug Cocktail + Ixekizumab)
STARTED
|
28
|
|
Period 2 (Drug Cocktail + Ixekizumab)
Received at Least 1 Dose of Study Drug
|
27
|
|
Period 2 (Drug Cocktail + Ixekizumab)
COMPLETED
|
26
|
|
Period 2 (Drug Cocktail + Ixekizumab)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Drug Cocktail /Drug Cocktail + Ixekizumab
Period 1: Participants received drug cocktail (100 mg Caffeine, 10 mg Warfarin \[plus vitamin K\], 20 mg Omeprazole, 30 mg Dextromethorphan, and 1 mg Midazolam) administered orally on Day 1. Participants resided at the Clinical Research Unit (CRU) until Day 2, and were discharged following collection of 24-hour pharmacokinetics (PK) samples for the determination of plasma concentrations of the cocktail drugs and metabolites.
Period 2: Participants received a 160 mg dose of Ixekizumab during an outpatient visit on Day 1 (3 to 7 days after Day 5 of Period 1) and were admitted to the CRU on Day 7 (±2 days) to receive the drug cocktail on the morning of Day 8 (Week 1). Participants received single 80 mg doses of Ixekizumab at outpatient visits on Day 15 (Week 2), Day 29 (Week 4), Day 43 (Week 6), Day 57 (Week 8), and Day 71 (Week 10). Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg Ixekizumab and the drug cocktail on the following morning (Day 85; Week 12).
|
|---|---|
|
Period 2 (Drug Cocktail + Ixekizumab)
Protocol Violation
|
1
|
|
Period 2 (Drug Cocktail + Ixekizumab)
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of Ixekizumab in Participants With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Overall Study
n=28 Participants
Participants received drug cocktail and drug cocktail + Ixekizumab.
|
|---|---|
|
Age, Continuous
|
41.8 Years
STANDARD_DEVIATION 14.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate (Midazolam)
Outcome measures
| Measure |
1 mg Midazolam
n=27 Participants
Participants received 1 mg of Midazolam on Day 1 of Period 1.
|
160 mg Ixekizumab + 1 mg Midazolam
n=26 Participants
Participants received 160 mg dose of Ixekizumab on Day 1 and 1 mg of Midazolam on Day 8 of Period 2.
|
80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam
n=25 Participants
Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 1 mg of Midazolam on the following morning (Day 85; Week 12) during Period 2.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam
|
4.56 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
4.92 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
4.83 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Midazolam)
Outcome measures
| Measure |
1 mg Midazolam
n=27 Participants
Participants received 1 mg of Midazolam on Day 1 of Period 1.
|
160 mg Ixekizumab + 1 mg Midazolam
n=26 Participants
Participants received 160 mg dose of Ixekizumab on Day 1 and 1 mg of Midazolam on Day 8 of Period 2.
|
80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam
n=25 Participants
Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 1 mg of Midazolam on the following morning (Day 85; Week 12) during Period 2.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Midazolam
|
16.6 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 28
|
15.9 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 27
|
15.4 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 34
|
PRIMARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdosePopulation: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Warfarin)
Outcome measures
| Measure |
1 mg Midazolam
n=27 Participants
Participants received 1 mg of Midazolam on Day 1 of Period 1.
|
160 mg Ixekizumab + 1 mg Midazolam
n=26 Participants
Participants received 160 mg dose of Ixekizumab on Day 1 and 1 mg of Midazolam on Day 8 of Period 2.
|
80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam
n=25 Participants
Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 1 mg of Midazolam on the following morning (Day 85; Week 12) during Period 2.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin
|
510 ng/mL
Geometric Coefficient of Variation 26
|
525 ng/mL
Geometric Coefficient of Variation 22
|
510 ng/mL
Geometric Coefficient of Variation 23
|
PRIMARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdosePopulation: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Warfarin)
Outcome measures
| Measure |
1 mg Midazolam
n=27 Participants
Participants received 1 mg of Midazolam on Day 1 of Period 1.
|
160 mg Ixekizumab + 1 mg Midazolam
n=26 Participants
Participants received 160 mg dose of Ixekizumab on Day 1 and 1 mg of Midazolam on Day 8 of Period 2.
|
80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam
n=25 Participants
Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 1 mg of Midazolam on the following morning (Day 85; Week 12) during Period 2.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Warfarin
|
17600 ng*h/mL
Geometric Coefficient of Variation 29
|
17700 ng*h/mL
Geometric Coefficient of Variation 31
|
16200 ng*h/mL
Geometric Coefficient of Variation 29
|
PRIMARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdosePopulation: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Dextromethorphan)
Outcome measures
| Measure |
1 mg Midazolam
n=27 Participants
Participants received 1 mg of Midazolam on Day 1 of Period 1.
|
160 mg Ixekizumab + 1 mg Midazolam
n=25 Participants
Participants received 160 mg dose of Ixekizumab on Day 1 and 1 mg of Midazolam on Day 8 of Period 2.
|
80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam
n=24 Participants
Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 1 mg of Midazolam on the following morning (Day 85; Week 12) during Period 2.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Dextromethorphan
|
0.691 ng/mL
Geometric Coefficient of Variation 291
|
0.878 ng/mL
Geometric Coefficient of Variation 202
|
0.658 ng/mL
Geometric Coefficient of Variation 285
|
PRIMARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdosePopulation: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Dextromethorphan)
Outcome measures
| Measure |
1 mg Midazolam
n=25 Participants
Participants received 1 mg of Midazolam on Day 1 of Period 1.
|
160 mg Ixekizumab + 1 mg Midazolam
n=24 Participants
Participants received 160 mg dose of Ixekizumab on Day 1 and 1 mg of Midazolam on Day 8 of Period 2.
|
80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam
n=23 Participants
Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 1 mg of Midazolam on the following morning (Day 85; Week 12) during Period 2.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Dextromethorphan
|
11.7 ng*h/mL
Geometric Coefficient of Variation 254
|
12.6 ng*h/mL
Geometric Coefficient of Variation 225
|
8.53 ng*h/mL
Geometric Coefficient of Variation 273
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdosePopulation: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)
Outcome measures
| Measure |
1 mg Midazolam
n=27 Participants
Participants received 1 mg of Midazolam on Day 1 of Period 1.
|
160 mg Ixekizumab + 1 mg Midazolam
n=26 Participants
Participants received 160 mg dose of Ixekizumab on Day 1 and 1 mg of Midazolam on Day 8 of Period 2.
|
80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam
n=25 Participants
Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 1 mg of Midazolam on the following morning (Day 85; Week 12) during Period 2.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole
Omeprazole
|
333 ng/mL
Geometric Coefficient of Variation 83
|
340 ng/mL
Geometric Coefficient of Variation 74
|
368 ng/mL
Geometric Coefficient of Variation 62
|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole
5-Hydroxyomeprazole
|
148 ng/mL
Geometric Coefficient of Variation 55
|
143 ng/mL
Geometric Coefficient of Variation 57
|
137 ng/mL
Geometric Coefficient of Variation 46
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdosePopulation: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)
Outcome measures
| Measure |
1 mg Midazolam
n=22 Participants
Participants received 1 mg of Midazolam on Day 1 of Period 1.
|
160 mg Ixekizumab + 1 mg Midazolam
n=23 Participants
Participants received 160 mg dose of Ixekizumab on Day 1 and 1 mg of Midazolam on Day 8 of Period 2.
|
80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam
n=21 Participants
Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 1 mg of Midazolam on the following morning (Day 85; Week 12) during Period 2.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole
Omeprazole
|
1060 ng*h/mL
Geometric Coefficient of Variation 104
|
829 ng*h/mL
Geometric Coefficient of Variation 129
|
913 ng*h/mL
Geometric Coefficient of Variation 107
|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole
5-Hydroxyomeprazole
|
519 ng*h/mL
Geometric Coefficient of Variation 28
|
475 ng*h/mL
Geometric Coefficient of Variation 25
|
455 ng*h/mL
Geometric Coefficient of Variation 24
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdosePopulation: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Caffeine)
Outcome measures
| Measure |
1 mg Midazolam
n=18 Participants
Participants received 1 mg of Midazolam on Day 1 of Period 1.
|
160 mg Ixekizumab + 1 mg Midazolam
n=21 Participants
Participants received 160 mg dose of Ixekizumab on Day 1 and 1 mg of Midazolam on Day 8 of Period 2.
|
80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam
n=13 Participants
Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 1 mg of Midazolam on the following morning (Day 85; Week 12) during Period 2.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Caffeine
|
2230 ng/mL
Geometric Coefficient of Variation 19
|
2220 ng/mL
Geometric Coefficient of Variation 22
|
2240 ng/mL
Geometric Coefficient of Variation 22
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdosePopulation: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to 48 hours (AUC\[0-48h\]) of CYP450 Substrate (Caffeine)
Outcome measures
| Measure |
1 mg Midazolam
n=13 Participants
Participants received 1 mg of Midazolam on Day 1 of Period 1.
|
160 mg Ixekizumab + 1 mg Midazolam
n=19 Participants
Participants received 160 mg dose of Ixekizumab on Day 1 and 1 mg of Midazolam on Day 8 of Period 2.
|
80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam
n=11 Participants
Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 1 mg of Midazolam on the following morning (Day 85; Week 12) during Period 2.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 48 Hours (AUC[0-48h]) of CYP450 Substrate-Caffeine
|
25000 ng*h/mL
Geometric Coefficient of Variation 48
|
22400 ng*h/mL
Geometric Coefficient of Variation 57
|
22400 ng*h/mL
Geometric Coefficient of Variation 36
|
Adverse Events
Drug Cocktail
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Drug Cocktail + Ixekizumab
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Drug Cocktail
n=28 participants at risk
Participants received drug cocktail (100 mg Caffeine, 10 mg Warfarin \[plus vitamin K\], 20 mg Omeprazole, 30 mg Dextromethorphan, and 1 mg Midazolam) administered orally on Day 1 of period 1.
|
Drug Cocktail + Ixekizumab
n=27 participants at risk
Participants received a 160 mg dose of Ixekizumab during an outpatient visit on Day 1 (3 to 7 days after Day 5 of Period 1) and were admitted to the CRU on Day 7 (±2 days) to receive the drug cocktail on the morning of Day 8 (Week 1). Participants received single 80 mg doses of Ixekizumab at outpatient visits on Day 15 (Week 2), Day 29 (Week 4), Day 43 (Week 6), Day 57 (Week 8), and Day 71 (Week 10). Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg Ixekizumab and the drug cocktail on the following morning (Day 85; Week 12).
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/28 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/28 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/28 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.00%
0/28 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/28 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/28 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/28 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/28 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/28 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
3.6%
1/28 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/28 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/28 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/28 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60