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PsoriasisPhase 1NCT03145948

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 Phase 1 study testing ABBV-553 in people with Psoriasis, run by AbbVie at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Psoriasis
What is being tested?
ABBV-553
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
4 sitesUnited States
Study dates
9 May 2017to 16 Aug 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Inclusion Criteria: - Male or female and between 18 and 55 years of age, inclusive, for Substudy 1, OR between 18 and 75 years of age, inclusive, for Substudy 2.

  • If female, participant must be of non-child bearing potential defined as either:
  1. 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.
  • Has a Static Physician's Global Assessment (sPGA) score ≥ 3.
  • Has a Body Surface Area (BSA) affected by Ps ≥ 10%. Exclusion Criteria: - Male participant who is considering fathering a child or donating sperm during the study or through 30 days after the last dose of study drug.
  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Anaheim Clinical Trials LLC /ID# 164101

    Anaheim, California, 92801

  • Abbvie Clinical Pharmacology Research Unit /ID# 163866

    Grayslake, Illinois, 60030

  • Progressive Medical Research /ID# 163868

    Port Orange, Florida, 32127

  • Providence Clinical Research /ID# 163867

    Toluca, California, 91606

Other trials in United States

About this study

Official title: 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

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.

Conditions
Psoriasis
Being tested
ABBV-553, Placebo
Keywords
Tolerability, Psoriasis, Pharmacokinetics, Safety, Healthy Volunteers
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-553Drug

    It is administered orally.

  • PlaceboDrug

    It is administered orally.

Study groups in NCT03145948
Study groupRoleWhat they receive
Arm AExperimentalParticipants, who are healthy volunteers, receiving ABBV-553 dose A or placebo
Receives: Drug: ABBV-553; Drug: Placebo
Arm BExperimentalParticipants, who are healthy volunteers, receiving ABBV-553 dose B or placebo
Receives: Drug: ABBV-553; Drug: Placebo
Arm CExperimentalParticipants, who are healthy volunteers, receiving ABBV-553 dose C or placebo
Receives: Drug: ABBV-553; Drug: Placebo
Arm DExperimentalParticipants, who are healthy volunteers, receiving ABBV-553 dose D or placebo
Receives: Drug: ABBV-553; Drug: Placebo
Arm EExperimentalParticipants with psoriasis receiving ABBV-553 dose B or placebo
Receives: Drug: ABBV-553; Drug: Placebo
Arm FExperimentalParticipants with psoriasis receiving ABBV-553 dose C or placebo
Receives: Drug: ABBV-553; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Substudy 1: Maximum observed plasma concentration (Cmax) of ABBV-553

    Maximum observed plasma concentration (Cmax) of ABBV-553

    Measured: Day 1

  2. Substudy 2: Maximum observed plasma concentration (Cmax) of ABBV-553

    Maximum observed plasma concentration (Cmax) of ABBV-553

    Measured: Day 1

  3. Substudy 1: Time to Cmax (peak time, Tmax)

    Time to Cmax (peak time, Tmax)

    Measured: Day 1

  4. Substudy 2: Time to Cmax (peak time, Tmax)

    Time to Cmax (peak time, Tmax)

    Measured: Day 1

  5. Substudy 1: Area under the concentration time curve (AUC) from time zero to 24 hours after dosing

    Area under the concentration time curve (AUC) from time zero to 24 hours after dosing

    Measured: Day 1

  6. Substudy 2: Area under the concentration time curve (AUC) from time zero to 24 hours after dosing

    Area under the concentration time curve (AUC) from time zero to 24 hours after dosing

    Measured: Day 1

  7. Substudy 1: Observed plasma concentration at the end of the dosing interval (Ctrough)

    Observed plasma concentration at the end of the dosing interval (Ctrough)

    Measured: Day 7 and Day 14

  8. Substudy 2: Observed plasma concentration at the end of the dosing interval (Ctrough)

    Observed plasma concentration at the end of the dosing interval (Ctrough)

    Measured: Day 28

  9. Substudy 1: Apparent clearance (CL/F)

    Apparent clearance (CL/F)

    Measured: Day 14

  10. Substudy 2: Apparent clearance (CL/F)

    Apparent clearance (CL/F)

    Measured: Day 28

  11. Substudy 1: Volume of distribution (Vβ/F)

    Volume of distribution (Vβ/F)

    Measured: Day 14

  12. Substudy 2: Volume of distribution (Vβ/F)

    Volume of distribution (Vβ/F)

    Measured: Day 28

  13. Substudy 1: Fraction excreted unchanged in urine (fe)

    Fraction excreted unchanged in urine (fe)

    Measured: Day 14

  14. Substudy 1: Apparent renal clearance (CLR)

    Apparent renal clearance (CLR)

    Measured: Day 14

Secondary outcomes (2)

  1. Substudy 2: Psoriasis Area and Severity Index (PASI)

    Percent improvement in PASI from Baseline

    Measured: Day 28

  2. Substudy 2: Self-Assessment of Psoriasis Symptoms (SAPS) scores

    Psoriasis subjects participating in Substudy 2 will complete the questionnaire at the designated clinic.

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2017
  2. Study start9 May 2017
  3. Primary completion16 Aug 2017
  4. Study completion16 Aug 2017

Why it stopped: Safety reason

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03145948
Sponsor's protocol ID
M16-058
Status last verified
Nov 2017
First submitted
5 May 2017
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-553 in people with Psoriasis, run by AbbVie at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Safety reason). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Substudy 1: Maximum observed plasma concentration (Cmax) of ABBV-553 (time frame: Day 1). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03145948.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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Clinical Trial NCT03145948 | AzTrials