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A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-553 in Healthy Volunteers and in Subjects With Psoriasis and Efficacy of ABBV-553 in Subjects With Psoriasis | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-553 in Healthy Volunteers and in Subjects With Psoriasis and Efficacy of ABBV-553 in Subjects With Psoriasis

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-553 in Healthy Volunteers and in Subjects With Psoriasis and Efficacy of ABBV-553 in Subjects With Psoriasis

NCT03145948•AbbVie

View on ClinicalTrials.gov

Summary

This is a study to assess the pharmacokinetics, safety and tolerability of multiple ascending oral doses of ABBV-553 in healthy volunteers and the pharmacokinetics, safety, tolerability and efficacy of multiple ascending oral doses of ABBV-553 in participants with psoriasis under non-fasting conditions.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•If female, participant must be of non-child bearing potential defined as either:
•a. Postmenopausal: Age \> 55 years with no menses for 12 or more months without an alternative medical cause. Postmenopausal: Age \<= 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle stimulating hormone (FSH) level \>= 40 IU/L (OR) b. Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
•Non-postmenopausal females must have a negative urine pregnancy test result at Screening, and a negative serum pregnancy test result on Day -2 or Day -1.
•Male participants who are sexually active with women of child bearing potential (WOCBP), even if the male participant has undergone a successful vasectomy, must agree to use condoms from Day 1 through at least 30 days after the last dose of study drug, and male participant agrees not to donate sperm at least 30 days after the last dose of study drug.
•Body Mass Index (BMI) \>= 18.0 to \<= 29.9 kg/m2 after rounding to the tenths decimal for Substudy 1 OR BMI \>= 18.0 to \<= 34.9 kg/m2 after rounding to the tenths decimal for Substudy 2. BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m).
•In the opinion of the Investigator, that the participant is in a condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead Electrocardiogram (ECG).
•Must voluntarily sign and date each informed consent form, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures and be willing to comply with the requirements of this study protocol.
•Additional criteria for Substudy 2:
•Has a clinical diagnosis of chronic plaque psoriasis (with a disease duration of at least 6 months).
•Has a Psoriasis Area and Severity Index (PASI) score ≥ 12.
+1 more criteria

Exclusion Criteria

•History of clinically significant sensitivity to any drug.
•History of epilepsy, any clinically significant cardiac (including any family history of long-QT syndrome or unexplained sudden death), respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
•History of gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
•Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the start of confinement (Day -2 or Day -1) or oral anti-infectives within 14 days prior to the start of confinement (Day -2 or Day -1)..
•Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis.
•Use of any medications, vitamins and/or herbal supplements within the 2-week period prior to study drug administration. For Substudy 2, medications used to treat chronic, stable medical conditions are allowed during screening and participation in the study unless the medication is specifically prohibited.

Locations (4)

Anaheim Clinical Trials LLC /ID# 164101

Anaheim, California, United States

Providence Clinical Research /ID# 163867

Toluca, California, United States

Progressive Medical Research /ID# 163868

Port Orange, Florida, United States

Abbvie Clinical Pharmacology Research Unit /ID# 163866

Grayslake, Illinois, United States

Key Dates

Start Date

May 9, 2017

Primary Completion Date

August 16, 2017

Completion Date

August 16, 2017

Last Updated

November 6, 2017

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

ABBV-553

DRUG

Placebo

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

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Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-553 in Healthy Volunteers and in Subjects With Psoriasis and Efficacy of ABBV-553 in Subjects With Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments