Clinical trial NCT03922607: A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque Psoriasis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Subjects With Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Keywords: Psoriasis
Chronic Plaque Psoriasis
ABBV-157
Healthy Volunteers
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Substudy 1: Cmax of ABBV-157
timeFrame: Up to approximately 14 days
measure: Substudy 1: Tmax of ABBV-157
timeFrame: Up to approximately 14 days
measure: Substudy 1: AUC0-24 Post-dose of ABBV-157
timeFrame: Day 1
measure: Substudy 1: Trough Concentration (Ctrough) of ABBV-157
timeFrame: Up to approximately 14 days
measure: Substudy 1: AUCtau of ABBV-157
timeFrame: Up to approximately 14 days
measure: Substudy 1: Apparent Oral Clearance (CL/F)
timeFrame: Day 14
measure: Substudy 1: Volume of Distribution (Vβ/F)
timeFrame: Day 14
measure: Substudy 1: Apparent Terminal Phase Elimination Constant (β)
timeFrame: Day 14
measure: Substudy 1: Elimination Half-Life (t1/2)
timeFrame: Day 14
measure: Substudy 1: Fraction Excreted Unchanged in Urine (fe)
timeFrame: Day 14
measure: Substudy 1: Apparent Renal Clearance (CLR)
timeFrame: Day 14
measure: Substudy 1: Accumulation ratio for Cmax
timeFrame: Up to approximately 14 days
measure: Substudy 1: Accumulation Ratio for AUCtau
timeFrame: Up to approximately 14 days
measure: Substudy 2: Cmax of ABBV-157
timeFrame: Up to approximately 28 days
measure: Substudy 2: Tmax of ABBV-157
timeFrame: Up to approximately 28 days
measure: Substudy 2: AUC0-24 Post-dose of ABBV-157
timeFrame: Day 1
measure: Substudy 2: AUCtau of ABBV-157
timeFrame: Day 28
measure: Substudy 2: Apparent Oral Clearance (CL/F)
timeFrame: Day 28
measure: Substudy 2: Volume of Distribution (Vβ/F)
timeFrame: Day 28
measure: Substudy 2: Apparent Terminal Phase Elimination Constant (β)
timeFrame: Day 28
measure: Substudy 2: Elimination Half-Life (t1/2)
timeFrame: Day 28
measure: Substudy 2: Accumulation ratio for Cmax
timeFrame: Up to approximately 28 days
measure: Substudy 2: Accumulation Ratio for AUCtau
timeFrame: Up to approximately 28 days
measure: Substudy 2: Trough Concentration (Ctrough) of ABBV-157
timeFrame: Up to approximately 28 days
measure: Substudy 2: Percent Change in Psoriasis Area and Severity Index (PASI) score from Baseline
timeFrame: Up to approximately 28 days
measure: Substudy 2: Change in Self-Assessment of Psoriasis Symptoms (SAPS) Score from Baseline
timeFrame: Up to approximately 28 days
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Day 58
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Derm Ctr /ID# 222593
state: Alabama
city: Phoenix
country: United States
facility: Alliance Dermatology and MOHs /ID# 222622
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials LLC /ID# 213645
state: California
city: Los Angeles
country: United States
facility: Dermatology Res. Assoc., CA /ID# 224980
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research /ID# 213339
state: California
city: Sandy Springs
country: United States
facility: Advanced Medical Research /ID# 216090
state: Georgia
city: Grayslake
country: United States
facility: Acpru /Id# 213639
state: Illinois
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 224699
state: Pennsylvania
city: Austin
country: United States
facility: PPD PH I Clinical Unit /ID# 213062
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies - Webster TX /ID# 217352
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: