Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03922607 | A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque Psoriasis | PHASE1 | COMPLETED | 65 | — | — | Jun 11, 2019 | Apr 13, 2021 | May 11, 2021 | 10 | United States |
Maximum observed plasma concentration (Cmax) of ABBV-157
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157.
Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau).
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Volume of Distribution (Vβ/F) of ABBV-157
Apparent Terminal phase elimination rate constant (β or Beta)
Terminal phase elimination half-life (t1/2) of ABBV-157
Fraction excreted unchanged in urine (fe)
Apparent Renal Clearance (CLR) of ABBV-157
Accumulation ratio for Cmax
Accumulation Ratio for AUCtau
Maximum observed plasma concentration (Cmax) of ABBV-157
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157.
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Volume of Distribution (Vβ/F) of ABBV-157
Apparent Terminal phase elimination rate constant (β or Beta)
Terminal phase elimination half-life (t1/2) of ABBV-157
Accumulation ratio for Cmax
Accumulation Ratio for AUCtau
Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157
Psoriasis Area and Severity Index (PASI) score quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity.
SAPS is a self-assessment questionnaire of psoriasis symptoms.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
| Arm | Type | Description |
|---|---|---|
| Substudy 2: Group 2 | EXPERIMENTAL | Participants with chronic plaque psoriasis will be administered with ABBV-157 dose D or matching placebo on Day 1 through Day 28 |
| Substudy 2: Group 1 | EXPERIMENTAL | Participants with chronic plaque psoriasis will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 28 |
| Substudy 1: Group 3 | EXPERIMENTAL | Participants, who are healthy volunteers, will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 14 |
| Substudy 1: Group 2 | EXPERIMENTAL | Participants, who are healthy volunteers, will be administered with ABBV-157 dose B or matching placebo on Day 1 through Day 14 |
| Substudy 1: Group 1 | EXPERIMENTAL | Participants, who are healthy volunteers, will be administered with ABBV-157 dose A or matching placebo on Day 1 through Day 14 |
| Name | Type | Description |
|---|---|---|
| ABBV-157 | DRUG | ABBV-157 will be administered orally as capsule |
| Placebo for ABBV-157 | DRUG | Placebo for ABBV-157 will be administered orally as capsule |
Inclusion Criteria: * Volunteer should be between 18 and 55 years of age and in general good health for Substudy 1 and participant with moderate to severe chronic plaque psoriasis between 18 and 75 years of age for Substudy 2 at the time of enrollment. * Participant should meet the laboratory asses...