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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

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ClinicalTrials.gov Identifier: NCT03922607
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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 Intervention/treatment Phase
Psoriasis Drug: ABBV-157 Drug: Placebo for ABBV-157 Phase 1

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Study Type : Interventional  (Clinical Trial)
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 10, 2019
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : October 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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




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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922607


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, Texas
PPD PH I Clinical Unit /ID# 213062 Recruiting
Austin, Texas, United States, 78744
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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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: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by AbbVie:
Psoriasis
Chronic Plaque Psoriasis
ABBV-157
Healthy Volunteers

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases