Back to resultsA Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABBV-157
Placebo for ABBV-157
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Chronic Plaque Psoriasis, ABBV-157, Healthy Volunteers
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.
Sites / Locations
- Total Skin and Beauty Derm Ctr /ID# 222593
- Alliance Dermatology and MOHs /ID# 222622
- Anaheim Clinical Trials LLC /ID# 213645
- Dermatology Res. Assoc., CA /ID# 224980
- Providence Clinical Research /ID# 213339
- Advanced Medical Research /ID# 216090
- Acpru /Id# 213639
- University of Pittsburgh MC /ID# 224699
- PPD PH I Clinical Unit /ID# 213062
- Center for Clinical Studies - Webster TX /ID# 217352
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Substudy 2: Group 2
Substudy 2: Group 1
Substudy 1: Group 3
Substudy 1: Group 2
Substudy 1: Group 1
Arm Description
Participants with chronic plaque psoriasis will be administered with ABBV-157 dose D or matching placebo on Day 1 through Day 28
Participants with chronic plaque psoriasis will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 28
Participants, who are healthy volunteers, will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 14
Participants, who are healthy volunteers, will be administered with ABBV-157 dose B or matching placebo on Day 1 through Day 14
Participants, who are healthy volunteers, will be administered with ABBV-157 dose A or matching placebo on Day 1 through Day 14
Outcomes
Primary Outcome Measures
Substudy 1: Cmax of ABBV-157
Maximum observed plasma concentration (Cmax) of ABBV-157
Substudy 1: Tmax of ABBV-157
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Substudy 1: AUC0-24 Post-dose of ABBV-157
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
Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157
Substudy 1: AUCtau of ABBV-157
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau).
Substudy 1: Apparent Oral Clearance (CL/F)
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Substudy 1: Volume of Distribution (Vβ/F)
Volume of Distribution (Vβ/F) of ABBV-157
Substudy 1: Apparent Terminal Phase Elimination Constant (β)
Apparent Terminal phase elimination rate constant (β or Beta)
Substudy 1: Elimination Half-Life (t1/2)
Terminal phase elimination half-life (t1/2) of ABBV-157
Substudy 1: Fraction Excreted Unchanged in Urine (fe)
Fraction excreted unchanged in urine (fe)
Substudy 1: Apparent Renal Clearance (CLR)
Apparent Renal Clearance (CLR) of ABBV-157
Substudy 1: Accumulation ratio for Cmax
Accumulation ratio for Cmax
Substudy 1: Accumulation Ratio for AUCtau
Accumulation Ratio for AUCtau
Substudy 2: Cmax of ABBV-157
Maximum observed plasma concentration (Cmax) of ABBV-157
Substudy 2: Tmax of ABBV-157
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Substudy 2: AUC0-24 Post-dose of ABBV-157
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
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)
Substudy 2: Apparent Oral Clearance (CL/F)
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Substudy 2: Volume of Distribution (Vβ/F)
Volume of Distribution (Vβ/F) of ABBV-157
Substudy 2: Apparent Terminal Phase Elimination Constant (β)
Apparent Terminal phase elimination rate constant (β or Beta)
Substudy 2: Elimination Half-Life (t1/2)
Terminal phase elimination half-life (t1/2) of ABBV-157
Substudy 2: Accumulation ratio for Cmax
Accumulation ratio for Cmax
Substudy 2: Accumulation Ratio for AUCtau
Accumulation Ratio for AUCtau
Substudy 2: Trough Concentration (Ctrough) of ABBV-157
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
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
SAPS is a self-assessment questionnaire of psoriasis symptoms.
Number of Participants With Adverse Events (AEs)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03922607
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
April 13, 2021 (Actual)
Study Completion Date
April 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, Chronic Plaque Psoriasis, ABBV-157, Healthy Volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Substudy 2: Group 2
Arm Type
Experimental
Arm Description
Participants with chronic plaque psoriasis will be administered with ABBV-157 dose D or matching placebo on Day 1 through Day 28
Arm Title
Substudy 2: Group 1
Arm Type
Experimental
Arm Description
Participants with chronic plaque psoriasis will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 28
Arm Title
Substudy 1: Group 3
Arm Type
Experimental
Arm Description
Participants, who are healthy volunteers, will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 14
Arm Title
Substudy 1: Group 2
Arm Type
Experimental
Arm Description
Participants, who are healthy volunteers, will be administered with ABBV-157 dose B or matching placebo on Day 1 through Day 14
Arm Title
Substudy 1: Group 1
Arm Type
Experimental
Arm Description
Participants, who are healthy volunteers, will be administered with ABBV-157 dose A or matching placebo on Day 1 through Day 14
Intervention Type
Drug
Intervention Name(s)
ABBV-157
Intervention Description
ABBV-157 will be administered orally as capsule
Intervention Type
Drug
Intervention Name(s)
Placebo for ABBV-157
Intervention Description
Placebo for ABBV-157 will be administered orally as capsule
Primary Outcome Measure Information:
Title
Substudy 1: Cmax of ABBV-157
Description
Maximum observed plasma concentration (Cmax) of ABBV-157
Time Frame
Up to approximately 14 days
Title
Substudy 1: Tmax of ABBV-157
Description
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Time Frame
Up to approximately 14 days
Title
Substudy 1: AUC0-24 Post-dose of ABBV-157
Description
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157.
Time Frame
Day 1
Title
Substudy 1: Trough Concentration (Ctrough) of ABBV-157
Description
Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157
Time Frame
Up to approximately 14 days
Title
Substudy 1: AUCtau of ABBV-157
Description
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau).
Time Frame
Up to approximately 14 days
Title
Substudy 1: Apparent Oral Clearance (CL/F)
Description
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Time Frame
Day 14
Title
Substudy 1: Volume of Distribution (Vβ/F)
Description
Volume of Distribution (Vβ/F) of ABBV-157
Time Frame
Day 14
Title
Substudy 1: Apparent Terminal Phase Elimination Constant (β)
Description
Apparent Terminal phase elimination rate constant (β or Beta)
Time Frame
Day 14
Title
Substudy 1: Elimination Half-Life (t1/2)
Description
Terminal phase elimination half-life (t1/2) of ABBV-157
Time Frame
Day 14
Title
Substudy 1: Fraction Excreted Unchanged in Urine (fe)
Description
Fraction excreted unchanged in urine (fe)
Time Frame
Day 14
Title
Substudy 1: Apparent Renal Clearance (CLR)
Description
Apparent Renal Clearance (CLR) of ABBV-157
Time Frame
Day 14
Title
Substudy 1: Accumulation ratio for Cmax
Description
Accumulation ratio for Cmax
Time Frame
Up to approximately 14 days
Title
Substudy 1: Accumulation Ratio for AUCtau
Description
Accumulation Ratio for AUCtau
Time Frame
Up to approximately 14 days
Title
Substudy 2: Cmax of ABBV-157
Description
Maximum observed plasma concentration (Cmax) of ABBV-157
Time Frame
Up to approximately 28 days
Title
Substudy 2: Tmax of ABBV-157
Description
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Time Frame
Up to approximately 28 days
Title
Substudy 2: AUC0-24 Post-dose of ABBV-157
Description
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157.
Time Frame
Day 1
Title
Substudy 2: AUCtau of ABBV-157
Description
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)
Time Frame
Day 28
Title
Substudy 2: Apparent Oral Clearance (CL/F)
Description
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Time Frame
Day 28
Title
Substudy 2: Volume of Distribution (Vβ/F)
Description
Volume of Distribution (Vβ/F) of ABBV-157
Time Frame
Day 28
Title
Substudy 2: Apparent Terminal Phase Elimination Constant (β)
Description
Apparent Terminal phase elimination rate constant (β or Beta)
Time Frame
Day 28
Title
Substudy 2: Elimination Half-Life (t1/2)
Description
Terminal phase elimination half-life (t1/2) of ABBV-157
Time Frame
Day 28
Title
Substudy 2: Accumulation ratio for Cmax
Description
Accumulation ratio for Cmax
Time Frame
Up to approximately 28 days
Title
Substudy 2: Accumulation Ratio for AUCtau
Description
Accumulation Ratio for AUCtau
Time Frame
Up to approximately 28 days
Title
Substudy 2: Trough Concentration (Ctrough) of ABBV-157
Description
Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157
Time Frame
Up to approximately 28 days
Title
Substudy 2: Percent Change in Psoriasis Area and Severity Index (PASI) score from Baseline
Description
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.
Time Frame
Up to approximately 28 days
Title
Substudy 2: Change in Self-Assessment of Psoriasis Symptoms (SAPS) Score from Baseline
Description
SAPS is a self-assessment questionnaire of psoriasis symptoms.
Time Frame
Up to approximately 28 days
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Up to Day 58
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Total Skin and Beauty Derm Ctr /ID# 222593
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Alliance Dermatology and MOHs /ID# 222622
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Anaheim Clinical Trials LLC /ID# 213645
City
Anaheim
State/Province
California
ZIP/Postal Code
92801-2658
Country
United States
Facility Name
Dermatology Res. Assoc., CA /ID# 224980
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Providence Clinical Research /ID# 213339
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Advanced Medical Research /ID# 216090
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328-6141
Country
United States
Facility Name
Acpru /Id# 213639
City
Grayslake
State/Province
Illinois
ZIP/Postal Code
60030
Country
United States
Facility Name
University of Pittsburgh MC /ID# 224699
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
PPD PH I Clinical Unit /ID# 213062
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
Facility Name
Center for Clinical Studies - Webster TX /ID# 217352
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque Psoriasis
We'll reach out to this number within 24 hrs