A Study to Investigate the Safety, Tolerability, Pharmacokinetic, and Efficacy of ABY-035/AFO2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-13

Study Completion Date

2020-09-22

Brief Summary

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The purpose of this first-in-human study of the formulation ABY-035/AFO2 is to investigate the safety, tolerability and efficacy after multiple doses in sequential escalating dose cohorts in psoriasis subjects.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

An exploratory, clinical study with 2 open-dose cohorts is designed to analyze the safety, tolerability, PK, and efficacy of ABY-035/AFO2 in the treatment of subjects with active plaque psoriasis.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1:75 mg ABY-035/AFO2

Cohort 1: 75 mg ABY-035/AFO2, once daily for 14 days

Group Type EXPERIMENTAL

ABY-035/AFO2

Intervention Type BIOLOGICAL

Analyze the safety, tolerability, PK, and efficacy of ABY-035/AFO2 that 25 subjects will receive for treatment of their active plaque psoriasis

Cohort 2: 150 mg ABY-035/AFO2

Cohort 2: 150 mg ABY-035/AFO2 once daily for up to 28 days

Group Type EXPERIMENTAL

ABY-035/AFO2

Intervention Type BIOLOGICAL

Analyze the safety, tolerability, PK, and efficacy of ABY-035/AFO2 that 25 subjects will receive for treatment of their active plaque psoriasis

Interventions

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ABY-035/AFO2

Analyze the safety, tolerability, PK, and efficacy of ABY-035/AFO2 that 25 subjects will receive for treatment of their active plaque psoriasis

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with plaque psoriasis at least 6 months prior to Screening, if suitable for systemic treatment or phototherapy, and if have a stable active plaque-type psoriasis (stable is defined as without clinically significant flares during the 12 weeks before the first dose). Subjects with psoriatic arthritis may be included if they have not received systemic treatment within the last 12 months and their disease is stable
* Subjects must use adequate contraceptive measures from the Screening Visit until 4 weeks after final administration of the investigational product
* Subject that has a maximum body weight of 243 pounds (110 kg)

Exclusion Criteria

* Subjects with psoriatic arthritis that have received systemic treatment within the last 12 months.
* Subjects will not be eligible if they have current forms of psoriasis other than chronic plaque-type (e.g. erythrodermic, guttate, or pustular)
* Subject that has a current drug-induced psoriasis form (e.g. a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* Subject that has a history of recurrent or medically important infections, a clinically significant candida infection or clinically significant skin infection with Staphylococcus aureus requiring systemic treatment in the last 12 months prior to the first administration of study drug
* Subject that smokes more than 15 cigarettes, or equivalent in tobacco, per day Subject with a history of suicide attempt or suicidal behavior
* Any live vaccination within 3 months prior to Screening
* Subject that is pregnant, intends to become pregnant during the course of the study, or is lactating

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No