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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03922607

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted July 1, 2020

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.

  • Condition or Disease:Psoriasis
  • Intervention/Treatment: Drug: ABBV-157
    Drug: Placebo for ABBV-157
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Sequential Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: October 2020
  • Estimated Study Completion Date: October 2020
Arms and interventions
Arm Intervention/treatment
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
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
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
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
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
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
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
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
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
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
Outcome Measures
  • Primary Outcome Measures: 1. Substudy 1: Cmax of ABBV-157 [ Time Frame: Up to approximately 14 days ]
    Maximum observed plasma concentration (Cmax) of ABBV-157
  • 2. Substudy 1: Tmax of ABBV-157 [ Time Frame: Up to approximately 14 days ]
    Time to maximum observed plasma concentration (Tmax) of ABBV-157
  • 3. 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.
  • 4. 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
  • 5. 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).
  • 6. 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.
  • 7. Substudy 1: Volume of Distribution (Vβ/F) [ Time Frame: Day 14 ]
    Volume of Distribution (Vβ/F) of ABBV-157
  • 8. Substudy 1: Apparent Terminal Phase Elimination Constant (β) [ Time Frame: Day 14 ]
    Apparent Terminal phase elimination rate constant (β or Beta)
  • 9. Substudy 1: Elimination Half-Life (t1/2) [ Time Frame: Day 14 ]
    Terminal phase elimination half-life (t1/2) of ABBV-157
  • 10. Substudy 1: Fraction Excreted Unchanged in Urine (fe) [ Time Frame: Day 14 ]
    Fraction excreted unchanged in urine (fe)
  • 11. Substudy 1: Apparent Renal Clearance (CLR) [ Time Frame: Day 14 ]
    Apparent Renal Clearance (CLR) of ABBV-157
  • 12. Substudy 1: Accumulation ratio for Cmax [ Time Frame: Up to approximately 14 days ]
    Accumulation ratio for Cmax
  • 13. Substudy 1: Accumulation Ratio for AUCtau [ Time Frame: Up to approximately 14 days ]
    Accumulation Ratio for AUCtau
  • 14. Substudy 2: Cmax of ABBV-157 [ Time Frame: Up to approximately 28 days ]
    Maximum observed plasma concentration (Cmax) of ABBV-157
  • 15. Substudy 2: Tmax of ABBV-157 [ Time Frame: Up to approximately 28 days ]
    Time to maximum observed plasma concentration (Tmax) of ABBV-157
  • 16. 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.
  • 17. 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)
  • 18. 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.
  • 19. Substudy 2: Volume of Distribution (Vβ/F) [ Time Frame: Day 28 ]
    Volume of Distribution (Vβ/F) of ABBV-157
  • 20. Substudy 2: Apparent Terminal Phase Elimination Constant (β) [ Time Frame: Day 28 ]
    Apparent Terminal phase elimination rate constant (β or Beta)
  • 21. Substudy 2: Elimination Half-Life (t1/2) [ Time Frame: Day 28 ]
    Terminal phase elimination half-life (t1/2) of ABBV-157
  • 22. Substudy 2: Accumulation ratio for Cmax [ Time Frame: Up to approximately 28 days ]
    Accumulation ratio for Cmax
  • 23. Substudy 2: Accumulation Ratio for AUCtau [ Time Frame: Up to approximately 28 days ]
    Accumulation Ratio for AUCtau
  • 24. 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
  • 25. 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.
  • 26. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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.

Contacts and Locations
Contacts

Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations

United States, California
Anaheim Clinical Trials LLC /ID# 213645
Anaheim

United States, California
Providence Clinical Research /ID# 213339
North Hollywood

United States, Georgia
Advanced Medical Research /ID# 216090
Sandy Springs

United States, Illinois
Acpru /Id# 213639
Grayslake

United States, Texas
PPD PH I Clinical Unit /ID# 213062
Austin

United States, Texas
Center for Clinical Studies - Webster TX /ID# 217352
Webster

Sponsors and Collaborators

AbbVie

Investigators

Study Director: AbbVie Inc. AbbVie

More Information
  • Responsible Party: AbbVie
  • ClinicalTrials.gov Identifier: NCT03922607 History of Changes
  • Other Study ID Numbers: M17-238
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: July 1, 2020
  • Last Verified: June 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • 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.: Yes
  • Keywords provided by AbbVie: Psoriasis
    Chronic Plaque Psoriasis
    ABBV-157
    Healthy Volunteers
  • Additional relevant MeSH terms: Psoriasis