Clinical trial NCT03580278: A Study to Investigate the Safety, Tolerability, Pharmacokinetic, and Efficacy of ABY-035/AFO2
Official title: A Safety, Tolerability, Pharmacokinetic, and Efficacy Study of ABY-035/AFO2 Given as Multiple Doses in Sequential Escalating Dose Cohorts in Psoriasis Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Affibody
Sponsor class: INDUSTRY
First posted: 2018-07-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with treatment-related Adverse Events as assessed by the principles of Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: 28 Days
measure: Number of subjects with treatment-related Adverse Events as assessed by the principles of Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: 42 Days
Secondary outcomes:
measure: Subjects´ level of anti-drug antibodies (ADAs) in the blood
timeFrame: 14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts
measure: If subjects have assessable pharmacokinetics (PK) of ABY-035
timeFrame: 14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts
measure: If subjects have assessable pharmacokinetics (PK) of ABY-035
timeFrame: 14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts
measure: Efficacy assessment: The change of the subjects´ scaling of a selected target plaque from baseline to the last visit
timeFrame: 14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts
measure: Efficacy assessment: The change of the subjects´erythema of a selected target plaque from baseline to the last visit
timeFrame: 14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts
measure: Efficacy assessment: The change of the subjects´ thickness of a selected target plaque from baseline to the last visit
timeFrame: 14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts
Other outcomes:
Locations:
city: Encino
country: United States
facility: Raoof, Joseph
state: California
Study officials:
affiliation: Encino Research Center
name: Tooraj Raoof, MD
role: PRINCIPAL_INVESTIGATOR
References: