A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque Psoriasis
- Conditions
- Psoriasis
- Interventions
- Drug: ABBV-157Drug: Placebo for ABBV-157
- Registration Number
- NCT03922607
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Substudy 1: Group 2 Placebo for ABBV-157 Participants, who are healthy volunteers, will be administered with ABBV-157 dose B or matching placebo on Day 1 through Day 14 Substudy 2: Group 1 Placebo for ABBV-157 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 ABBV-157 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 ABBV-157 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 ABBV-157 Participants, who are healthy volunteers, will be administered with ABBV-157 dose A or matching placebo on Day 1 through Day 14 Substudy 2: Group 2 ABBV-157 Participants with chronic plaque psoriasis will be administered with ABBV-157 dose D or matching placebo on Day 1 through Day 28 Substudy 1: Group 3 Placebo for ABBV-157 Participants, who are healthy volunteers, will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 14 Substudy 2: Group 2 Placebo for ABBV-157 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 ABBV-157 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 1 Placebo for ABBV-157 Participants, who are healthy volunteers, will be administered with ABBV-157 dose A or matching placebo on Day 1 through Day 14
- Primary Outcome Measures
Name Time Method 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: Elimination Half-Life (t1/2) Day 28 Terminal phase elimination half-life (t1/2) 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 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 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 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: 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 AUCtau Up to approximately 14 days Accumulation Ratio for 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 2: Volume of Distribution (Vβ/F) Day 28 Volume of Distribution (Vβ/F) of ABBV-157
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: 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: Apparent Oral Clearance (CL/F) Day 14 Clearance is defined as the volume of plasma cleared of the drug per unit time.
Substudy 1: Elimination Half-Life (t1/2) Day 14 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 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 2: Cmax of ABBV-157 Up to approximately 28 days Maximum observed plasma concentration (Cmax) of ABBV-157
Substudy 2: Apparent Terminal Phase Elimination Constant (β) Day 28 Apparent Terminal phase elimination rate constant (β or Beta)
Substudy 2: Accumulation Ratio for AUCtau Up to approximately 28 days Accumulation Ratio for AUCtau
Substudy 2: AUCtau of ABBV-157 Day 28 The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)
Substudy 1: Accumulation ratio for Cmax Up to approximately 14 days Accumulation ratio for Cmax
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.
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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Total Skin and Beauty Derm Ctr /ID# 222593
🇺🇸Birmingham, Alabama, United States
Anaheim Clinical Trials LLC /ID# 213645
🇺🇸Anaheim, California, United States
Dermatology Res. Assoc., CA /ID# 224980
🇺🇸Los Angeles, California, United States
Providence Clinical Research /ID# 213339
🇺🇸North Hollywood, California, United States
Advanced Medical Research /ID# 216090
🇺🇸Sandy Springs, Georgia, United States
University of Pittsburgh MC /ID# 224699
🇺🇸Pittsburgh, Pennsylvania, United States
PPD PH I Clinical Unit /ID# 213062
🇺🇸Austin, Texas, United States
Center for Clinical Studies - Webster TX /ID# 217352
🇺🇸Webster, Texas, United States
Alliance Dermatology and MOHs /ID# 222622
🇺🇸Phoenix, Arizona, United States
Acpru /Id# 213639
🇺🇸Grayslake, Illinois, United States