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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03922607
Recruitment Status : Completed
First Posted : April 22, 2019
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date May 11, 2021
Actual Study Start Date  ICMJE June 11, 2019
Actual Primary Completion Date April 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2020)
  • Substudy 1: Cmax of ABBV-157 [ Time Frame: Up to approximately 14 days ]
    Maximum observed plasma concentration (Cmax) of ABBV-157
  • Substudy 1: Tmax of ABBV-157 [ Time Frame: Up to approximately 14 days ]
    Time to maximum observed plasma concentration (Tmax) of ABBV-157
  • Substudy 1: AUC0-24 Post-dose of ABBV-157 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Day 14 ]
    Clearance is defined as the volume of plasma cleared of the drug per unit time.
  • Substudy 1: Volume of Distribution (Vβ/F) [ Time Frame: Day 14 ]
    Volume of Distribution (Vβ/F) of ABBV-157
  • Substudy 1: Apparent Terminal Phase Elimination Constant (β) [ Time Frame: Day 14 ]
    Apparent Terminal phase elimination rate constant (β or Beta)
  • Substudy 1: Elimination Half-Life (t1/2) [ Time Frame: Day 14 ]
    Terminal phase elimination half-life (t1/2) of ABBV-157
  • Substudy 1: Fraction Excreted Unchanged in Urine (fe) [ Time Frame: Day 14 ]
    Fraction excreted unchanged in urine (fe)
  • Substudy 1: Apparent Renal Clearance (CLR) [ Time Frame: Day 14 ]
    Apparent Renal Clearance (CLR) of ABBV-157
  • Substudy 1: Accumulation ratio for Cmax [ Time Frame: Up to approximately 14 days ]
    Accumulation ratio for Cmax
  • Substudy 1: Accumulation Ratio for AUCtau [ Time Frame: Up to approximately 14 days ]
    Accumulation Ratio for AUCtau
  • Substudy 2: Cmax of ABBV-157 [ Time Frame: Up to approximately 28 days ]
    Maximum observed plasma concentration (Cmax) of ABBV-157
  • Substudy 2: Tmax of ABBV-157 [ Time Frame: Up to approximately 28 days ]
    Time to maximum observed plasma concentration (Tmax) of ABBV-157
  • Substudy 2: AUC0-24 Post-dose of ABBV-157 [ Time Frame: 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 [ Time Frame: Day 28 ]
    The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)
  • Substudy 2: Apparent Oral Clearance (CL/F) [ Time Frame: Day 28 ]
    Clearance is defined as the volume of plasma cleared of the drug per unit time.
  • Substudy 2: Volume of Distribution (Vβ/F) [ Time Frame: Day 28 ]
    Volume of Distribution (Vβ/F) of ABBV-157
  • Substudy 2: Apparent Terminal Phase Elimination Constant (β) [ Time Frame: Day 28 ]
    Apparent Terminal phase elimination rate constant (β or Beta)
  • Substudy 2: Elimination Half-Life (t1/2) [ Time Frame: Day 28 ]
    Terminal phase elimination half-life (t1/2) of ABBV-157
  • Substudy 2: Accumulation ratio for Cmax [ Time Frame: Up to approximately 28 days ]
    Accumulation ratio for Cmax
  • Substudy 2: Accumulation Ratio for AUCtau [ Time Frame: Up to approximately 28 days ]
    Accumulation Ratio for AUCtau
  • Substudy 2: Trough Concentration (Ctrough) of ABBV-157 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to approximately 28 days ]
    SAPS is a self-assessment questionnaire of psoriasis symptoms.
  • Number of Participants With Adverse Events (AEs) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Substudy 1: Cmax of ABBV-157 [ Time Frame: Up to approximately 14 days ]
    Maximum observed plasma concentration (Cmax) of ABBV-157
  • Substudy 1: Tmax of ABBV-157 [ Time Frame: Up to approximately 14 days ]
    Time to maximum observed plasma concentration (Tmax) of ABBV-157
  • Substudy 1: AUC0-24 Post-dose of ABBV-157 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Day 14 ]
    Clearance is defined as the volume of plasma cleared of the drug per unit time.
  • Substudy 1: Volume of Distribution (Vβ/F) [ Time Frame: Day 14 ]
    Volume of Distribution (Vβ/F) of ABBV-157
  • Substudy 1: Apparent Terminal Phase Elimination Constant (β) [ Time Frame: Day 14 ]
    Apparent Terminal phase elimination rate constant (β or Beta)
  • Substudy 1: Elimination Half-Life (t1/2) [ Time Frame: Day 14 ]
    Terminal phase elimination half-life (t1/2) of ABBV-157
  • Substudy 1: Fraction Excreted Unchanged in Urine (fe) [ Time Frame: Day 14 ]
    Fraction excreted unchanged in urine (fe)
  • Substudy 1: Apparent Renal Clearance (CLR) [ Time Frame: Day 14 ]
    Apparent Renal Clearance (CLR) of ABBV-157
  • Substudy 1: Accumulation ratio for Cmax [ Time Frame: Up to approximately 14 days ]
    Accumulation ratio for Cmax
  • Substudy 1: Accumulation Ratio for AUCtau [ Time Frame: Up to approximately 14 days ]
    Accumulation Ratio for AUCtau
  • Substudy 2: Cmax of ABBV-157 [ Time Frame: Up to approximately 28 days ]
    Maximum observed plasma concentration (Cmax) of ABBV-157
  • Substudy 2: Tmax of ABBV-157 [ Time Frame: Up to approximately 28 days ]
    Time to maximum observed plasma concentration (Tmax) of ABBV-157
  • Substudy 2: AUC0-24 Post-dose of ABBV-157 [ Time Frame: 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 [ Time Frame: Day 28 ]
    The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)
  • Substudy 2: Apparent Oral Clearance (CL/F) [ Time Frame: Day 28 ]
    Clearance is defined as the volume of plasma cleared of the drug per unit time.
  • Substudy 2: Volume of Distribution (Vβ/F) [ Time Frame: Day 28 ]
    Volume of Distribution (Vβ/F) of ABBV-157
  • Substudy 2: Accumulation ratio for Cmax [ Time Frame: Up to approximately 28 days ]
    Accumulation ratio for Cmax
  • Substudy 2: Accumulation Ratio for AUCtau [ Time Frame: Up to approximately 28 days ]
    Accumulation Ratio for AUCtau
  • Substudy 2: Trough Concentration (Ctrough) of ABBV-157 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to approximately 28 days ]
    SAPS is a self-assessment questionnaire of psoriasis symptoms.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque Psoriasis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: ABBV-157
    ABBV-157 will be administered orally as capsule
  • Drug: Placebo for ABBV-157
    Placebo for ABBV-157 will be administered orally as capsule
Study Arms  ICMJE
  • Experimental: Substudy 2: Group 2
    Participants with chronic plaque psoriasis will be administered with ABBV-157 dose D or matching placebo on Day 1 through Day 28
    Interventions:
    • Drug: ABBV-157
    • Drug: Placebo for ABBV-157
  • Experimental: Substudy 2: Group 1
    Participants with chronic plaque psoriasis will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 28
    Interventions:
    • Drug: ABBV-157
    • Drug: Placebo for ABBV-157
  • Experimental: Substudy 1: Group 3
    Participants, who are healthy volunteers, will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 14
    Interventions:
    • Drug: ABBV-157
    • Drug: Placebo for ABBV-157
  • Experimental: Substudy 1: Group 2
    Participants, who are healthy volunteers, will be administered with ABBV-157 dose B or matching placebo on Day 1 through Day 14
    Interventions:
    • Drug: ABBV-157
    • Drug: Placebo for ABBV-157
  • Experimental: Substudy 1: Group 1
    Participants, who are healthy volunteers, will be administered with ABBV-157 dose A or matching placebo on Day 1 through Day 14
    Interventions:
    • Drug: ABBV-157
    • Drug: Placebo for ABBV-157
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2021)
65
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2019)
60
Actual Study Completion Date  ICMJE April 13, 2021
Actual Primary Completion Date April 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03922607
Other Study ID Numbers  ICMJE M17-238
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP