Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection (NCT NCT02640482)
NCT ID: NCT02640482
Last Updated: 2021-07-16
Results Overview
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was the noninferiority of the percentage of participants who achieved SVR12 in Arm A Double Blind (DB) Active Drug excluding prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylatedinterferon (pegIFN) failures compared with the historical control rate for patients treated with the current standard of care (SOF + RBV for 12 weeks).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
12 weeks after the last actual dose of active study drug
Results posted on
2021-07-16
Participant Flow
Safety population: All participants who received at least one dose of study drug.
A total of 304 subjects were randomized and 302 subjects received at least 1 dose of study drug.
Participant milestones
| Measure |
Arm A DB Active Drug
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period)
|
Arm B DB Placebo Then OL Active Drug
Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period) followed by ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label \[OL\] treatment period)
|
|---|---|---|
|
Overall Study
STARTED
|
202
|
100
|
|
Overall Study
COMPLETED
|
199
|
100
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Arm A DB Active Drug
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period)
|
Arm B DB Placebo Then OL Active Drug
Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period) followed by ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label \[OL\] treatment period)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection
Baseline characteristics by cohort
| Measure |
Arm A DB Active Drug
n=202 Participants
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period)
|
Arm B DB Placebo Then OL Active Drug
n=100 Participants
Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period) followed by ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label \[OL\] treatment period)
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.77 years
STANDARD_DEVIATION 12.79 • n=5 Participants
|
57.60 years
STANDARD_DEVIATION 12.04 • n=7 Participants
|
57.04 years
STANDARD_DEVIATION 12.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the last actual dose of active study drugPopulation: All randomized participants who received at least one dose of study drug in Arm A DB excluding participants with prior SOF + RBV ± pegIFN failures.
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was the noninferiority of the percentage of participants who achieved SVR12 in Arm A Double Blind (DB) Active Drug excluding prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylatedinterferon (pegIFN) failures compared with the historical control rate for patients treated with the current standard of care (SOF + RBV for 12 weeks).
Outcome measures
| Measure |
Arm A DB Active Drug
n=196 Participants
Arm A DB Active Drug: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period)
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Noninferiority Analysis
|
99.5 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after the last actual dose of active study drugPopulation: All randomized participants who received at least one dose of study drug in Arm A DB excluding participants with prior SOF + RBV ± pegIFN failures.
SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. The secondary efficacy endpoint was the superiority of the percentage of participants who achieved SVR12 in Arm A Double Blind (DB) Active Drug excluding prior SOF + RBV ± pegIFN failures compared with the historical control rate for patients treated with the current standard of care (SOF + RBV for 12 weeks). As pre-specified in the study protocol, the primary outcome measure and the secondary outcome measure are not tested independently from each other. Rather, the two measures are ranked in a fixed sequential testing procedure that only if success was demonstrated for the primary outcome (i.e. non-inferiority test of Arm A SVR12 rate to the standard of care) did we test the first secondary outcome (i.e. superiority test of Arm A SVR12 rate to the standard of care).
Outcome measures
| Measure |
Arm A DB Active Drug
n=196 Participants
Arm A DB Active Drug: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period)
|
|---|---|
|
Percentage of Participants With SVR12 in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Superiority Analysis
|
99.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 12 post baselinePopulation: All randomized participants who received at least one dose of study drug in Arm A DB excluding participants with prior SOF + RBV ± pegIFN failures.
On-treatment virologic failure was defined as confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value of post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Outcome measures
| Measure |
Arm A DB Active Drug
n=196 Participants
Arm A DB Active Drug: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period)
|
|---|---|
|
Percentage of Participants With On-treatment Virologic Failure in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures
|
0.0 percentage of participants
Interval 0.0 to 1.9
|
SECONDARY outcome
Timeframe: Between End of Treatment (Week 12) and 12 weeks after the last dose of Arm A DB active drug (up to Week 24)Population: All randomized participants who received at least 1 dose of study drug in Arm A DB with HCV RNA \< LLOQ at the final treatment visit who completed the DB treatment, excluding participants with prior SOF + RBV ± pegIFN failures.
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of DB treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment, excluding reinfection.
Outcome measures
| Measure |
Arm A DB Active Drug
n=195 Participants
Arm A DB Active Drug: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period)
|
|---|---|
|
Percentage of Participants With Post-treatment Relapse in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures
|
0.0 percentage of participants
Interval 0.0 to 1.9
|
SECONDARY outcome
Timeframe: 12 weeks after the last actual dose of active study drugPopulation: All randomized participants who received at least one dose of study drug in Arm A DB with prior SOF + RBV ± pegIFN failures.
SVR12 was defined as HCV RNA level \<LLOQ 12 weeks after the last dose of active study drug.
Outcome measures
| Measure |
Arm A DB Active Drug
n=6 Participants
Arm A DB Active Drug: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period)
|
|---|---|
|
Percentage of Participants With SVR12 in Arm A DB Active Drug With Prior SOF + RBV ± pegIFN Failure
|
100 percentage of participants
|
Adverse Events
Arm A DB Active Drug
Serious events: 3 serious events
Other events: 75 other events
Deaths: 0 deaths
Arm B DB Placebo
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Arm B OL Active Drug
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A DB Active Drug
n=202 participants at risk
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period)
|
Arm B DB Placebo
n=100 participants at risk
Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period)
|
Arm B OL Active Drug
n=100 participants at risk
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label \[OL\] treatment period)
|
|---|---|---|---|
|
Gastrointestinal disorders
Haemorrhoids
|
0.50%
1/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.50%
1/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.50%
1/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.50%
1/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
1.0%
1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
1.0%
1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
Other adverse events
| Measure |
Arm A DB Active Drug
n=202 participants at risk
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period)
|
Arm B DB Placebo
n=100 participants at risk
Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period)
|
Arm B OL Active Drug
n=100 participants at risk
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label \[OL\] treatment period)
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.9%
20/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
3.0%
3/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
5.0%
5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Nausea
|
7.4%
15/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
4.0%
4/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
8.0%
8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Asthenia
|
9.4%
19/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
8.0%
8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
5.0%
5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Fatigue
|
11.4%
23/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
10.0%
10/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
5.0%
5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
Dizziness
|
3.0%
6/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
5.0%
5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
1.0%
1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
Headache
|
11.9%
24/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
12.0%
12/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
8.0%
8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
4/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
5.0%
5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
1.0%
1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
12/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
6.0%
6/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
5.0%
5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
|
Vascular disorders
Hypertension
|
0.99%
2/202 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
5.0%
5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
2.0%
2/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the double-blind (DB) period; TEAEs and TESAEs were also collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks) for all participants in the open-label (OL) period.
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug (or until prior to the first dose of open-label active drug for subjects who received DB placebo then OL active study drug) and were collected whether elicited or spontaneously reported by the participant.
|
Additional Information
Global Medical Services
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