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NCT Number: NCT03922607

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Total Skin and Beauty Derm Ctr /ID# 222593, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-157

Drug

ABBV-157 will be administered orally as capsule

Placebo for ABBV-157

Drug

Placebo for ABBV-157 will be administered orally as capsule

Primary outcomes

  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.

  27. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 22, 2019
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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