Psoriasis
Conditions
Keywords
Psoriasis, Chronic Plaque Psoriasis, ABBV-157, Healthy Volunteers
Brief summary
This is a study to evaluate pharmacokinetics (PK), safety and tolerability of ABBV-157 in healthy volunteers and in participants with chronic plaque psoriasis, and to evaluate the efficacy of ABBV-157 in the participants with psoriasis. This study consists of two substudies. Substudy 1 is a randomized, double-blind, placebo-controlled evaluation of multiple ascending oral doses of ABBV-157 in healthy adult volunteers. Substudy 2 is a randomized, double-blind, placebo-controlled study in which participants with moderate to severe chronic plaque psoriasis will be administered multiple oral doses of ABBV-157.
Interventions
DRUGABBV-157
ABBV-157 will be administered orally as capsule
DRUGPlacebo for ABBV-157
Placebo for ABBV-157 will be administered orally as capsule
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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 assessments as mentioned in the protocol.
Exclusion criteria
* Participant has a history of epilepsy, any significant cardiac, respiratory, renal, hepatic, gastrointestinal, opthalmologic, hematologic,or psychiatric disease or disorder, or any uncontrolled medical illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Substudy 2: AUC0-24 Post-dose of ABBV-157 | Day 1 | Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157. |
| Substudy 2: AUCtau of ABBV-157 | Day 28 | The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau) |
| Substudy 2: Apparent Oral Clearance (CL/F) | Day 28 | Clearance is defined as the volume of plasma cleared of the drug per unit time. |
| Substudy 1: Cmax of ABBV-157 | Up to approximately 14 days | Maximum observed plasma concentration (Cmax) of ABBV-157 |
| Substudy 1: Tmax of ABBV-157 | Up to approximately 14 days | Time to maximum observed plasma concentration (Tmax) of ABBV-157 |
| Substudy 1: AUC0-24 Post-dose of ABBV-157 | Day 1 | Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157. |
| Substudy 1: Trough Concentration (Ctrough) of ABBV-157 | Up to approximately 14 days | Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157 |
| Substudy 1: AUCtau of ABBV-157 | Up to approximately 14 days | The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau). |
| Substudy 1: Apparent Oral Clearance (CL/F) | Day 14 | Clearance is defined as the volume of plasma cleared of the drug per unit time. |
| Substudy 1: Volume of Distribution (Vβ/F) | Day 14 | Volume of Distribution (Vβ/F) of ABBV-157 |
| Substudy 1: Apparent Terminal Phase Elimination Constant (β) | Day 14 | Apparent Terminal phase elimination rate constant (β or Beta) |
| Substudy 1: Elimination Half-Life (t1/2) | Day 14 | Terminal phase elimination half-life (t1/2) of ABBV-157 |
| Substudy 1: Fraction Excreted Unchanged in Urine (fe) | Day 14 | Fraction excreted unchanged in urine (fe) |
| Substudy 1: Apparent Renal Clearance (CLR) | Day 14 | Apparent Renal Clearance (CLR) of ABBV-157 |
| Substudy 1: Accumulation ratio for Cmax | Up to approximately 14 days | Accumulation ratio for Cmax |
| Substudy 1: Accumulation Ratio for AUCtau | Up to approximately 14 days | Accumulation Ratio for AUCtau |
| Substudy 2: Cmax of ABBV-157 | Up to approximately 28 days | Maximum observed plasma concentration (Cmax) of ABBV-157 |
| Substudy 2: Tmax of ABBV-157 | Up to approximately 28 days | Time to maximum observed plasma concentration (Tmax) of ABBV-157 |
| Substudy 2: Volume of Distribution (Vβ/F) | Day 28 | Volume of Distribution (Vβ/F) of ABBV-157 |
| Substudy 2: Apparent Terminal Phase Elimination Constant (β) | Day 28 | Apparent Terminal phase elimination rate constant (β or Beta) |
| Substudy 2: Elimination Half-Life (t1/2) | Day 28 | Terminal phase elimination half-life (t1/2) of ABBV-157 |
| Substudy 2: Accumulation ratio for Cmax | Up to approximately 28 days | Accumulation ratio for Cmax |
| Substudy 2: Accumulation Ratio for AUCtau | Up to approximately 28 days | Accumulation Ratio for AUCtau |
| Substudy 2: Trough Concentration (Ctrough) of ABBV-157 | Up to approximately 28 days | Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157 |
| Substudy 2: Percent Change in Psoriasis Area and Severity Index (PASI) score from Baseline | Up to approximately 28 days | 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. |
| Substudy 2: Change in Self-Assessment of Psoriasis Symptoms (SAPS) Score from Baseline | Up to approximately 28 days | SAPS is a self-assessment questionnaire of psoriasis symptoms. |
| Number of Participants With Adverse Events (AEs) | Up to Day 58 | 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. |
Countries
United States
Outcome results
None listed