A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922607
• Other study ID #: M17-238
• Status: Completed
• Phase: Phase 1
• Start date: June 11, 2019
• Est. completion date: April 13, 2021

Study information

• Verified date: May 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 13, 2021
• Est. primary completion date: April 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• ABBV-157
ABBV-157 will be administered orally as capsule
• Placebo for ABBV-157
Placebo for ABBV-157 will be administered orally as capsule

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials LLC /ID# 213645	Anaheim	California
United States	PPD PH I Clinical Unit /ID# 213062	Austin	Texas
United States	Total Skin and Beauty Derm Ctr /ID# 222593	Birmingham	Alabama
United States	Acpru /Id# 213639	Grayslake	Illinois
United States	Dermatology Res. Assoc., CA /ID# 224980	Los Angeles	California
United States	Providence Clinical Research /ID# 213339	North Hollywood	California
United States	Alliance Dermatology and MOHs /ID# 222622	Phoenix	Arizona
United States	University of Pittsburgh MC /ID# 224699	Pittsburgh	Pennsylvania
United States	Advanced Medical Research /ID# 216090	Sandy Springs	Georgia
United States	Center for Clinical Studies - Webster TX /ID# 217352	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substudy 1: Cmax of ABBV-157	Maximum observed plasma concentration (Cmax) of ABBV-157	Up to approximately 14 days
Primary	Substudy 1: Tmax of ABBV-157	Time to maximum observed plasma concentration (Tmax) of ABBV-157	Up to approximately 14 days
Primary	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.	Day 1
Primary	Substudy 1: Trough Concentration (Ctrough) of ABBV-157	Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157	Up to approximately 14 days
Primary	Substudy 1: AUCtau of ABBV-157	The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau).	Up to approximately 14 days
Primary	Substudy 1: Apparent Oral Clearance (CL/F)	Clearance is defined as the volume of plasma cleared of the drug per unit time.	Day 14
Primary	Substudy 1: Volume of Distribution (Vß/F)	Volume of Distribution (Vß/F) of ABBV-157	Day 14
Primary	Substudy 1: Apparent Terminal Phase Elimination Constant (ß)	Apparent Terminal phase elimination rate constant (ß or Beta)	Day 14
Primary	Substudy 1: Elimination Half-Life (t1/2)	Terminal phase elimination half-life (t1/2) of ABBV-157	Day 14
Primary	Substudy 1: Fraction Excreted Unchanged in Urine (fe)	Fraction excreted unchanged in urine (fe)	Day 14
Primary	Substudy 1: Apparent Renal Clearance (CLR)	Apparent Renal Clearance (CLR) of ABBV-157	Day 14
Primary	Substudy 1: Accumulation ratio for Cmax	Accumulation ratio for Cmax	Up to approximately 14 days
Primary	Substudy 1: Accumulation Ratio for AUCtau	Accumulation Ratio for AUCtau	Up to approximately 14 days
Primary	Substudy 2: Cmax of ABBV-157	Maximum observed plasma concentration (Cmax) of ABBV-157	Up to approximately 28 days
Primary	Substudy 2: Tmax of ABBV-157	Time to maximum observed plasma concentration (Tmax) of ABBV-157	Up to approximately 28 days
Primary	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.	Day 1
Primary	Substudy 2: AUCtau of ABBV-157	The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)	Day 28
Primary	Substudy 2: Apparent Oral Clearance (CL/F)	Clearance is defined as the volume of plasma cleared of the drug per unit time.	Day 28
Primary	Substudy 2: Volume of Distribution (Vß/F)	Volume of Distribution (Vß/F) of ABBV-157	Day 28
Primary	Substudy 2: Apparent Terminal Phase Elimination Constant (ß)	Apparent Terminal phase elimination rate constant (ß or Beta)	Day 28
Primary	Substudy 2: Elimination Half-Life (t1/2)	Terminal phase elimination half-life (t1/2) of ABBV-157	Day 28
Primary	Substudy 2: Accumulation ratio for Cmax	Accumulation ratio for Cmax	Up to approximately 28 days
Primary	Substudy 2: Accumulation Ratio for AUCtau	Accumulation Ratio for AUCtau	Up to approximately 28 days
Primary	Substudy 2: Trough Concentration (Ctrough) of ABBV-157	Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157	Up to approximately 28 days
Primary	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.	Up to approximately 28 days
Primary	Substudy 2: Change in Self-Assessment of Psoriasis Symptoms (SAPS) Score from Baseline	SAPS is a self-assessment questionnaire of psoriasis symptoms.	Up to approximately 28 days
Primary	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.	Up to Day 58