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

A Safety, Tolerability, Pharmacokinetic, and Efficacy Study of ABY-035/AFO2 Given as Multiple Doses in Sequential Escalating Dose Cohorts in Psoriasis Subjects

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Biological: ABY-035/AFO2

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 16133
      • Raoof, Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1:75 mg ABY-035/AFO2; Cohort 1: 75 mg ABY-035/AFO2, once daily for 14 days	Biological: 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
EXPERIMENTAL: Cohort 2: 150 mg ABY-035/AFO2; Cohort 2: 150 mg ABY-035/AFO2 once daily for up to 28 days	Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with treatment-related Adverse Events as assessed by the principles of Common Terminology Criteria for Adverse Events (CTCAE)	5 male and female psoriasis subjects will be enrolled to obtain who complete treatment or drop out due to adverse events for Cohorts 1 and 2	28 Days
Number of subjects with treatment-related Adverse Events as assessed by the principles of Common Terminology Criteria for Adverse Events (CTCAE)	20 male and female psoriasis subjects will be enrolled to obtain who complete treatment or drop out due to adverse events for Cohort 3	42 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects´ level of anti-drug antibodies (ADAs) in the blood	To assess the immunogenicity of ABY-035 after multiple doses of ABY 035/AFO2 in psoriasis subjects	14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts
If subjects have assessable pharmacokinetics (PK) of ABY-035	To investigate the peak plasma concentration (Cmax ) of ABY-035 after multiple doses of ABY-035/AFO2 in psoriasis subjects	14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts
If subjects have assessable pharmacokinetics (PK) of ABY-035	To investigate the Area under the curve (AUC) versus time curve of ABY-035/AFO2 in psoriasis subjects	14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts
Efficacy assessment: The change of the subjects´ scaling of a selected target plaque from baseline to the last visit	The results will be summarized as number and percent by visit. Tables from baseline will be prepared for all timepoints	14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts
Efficacy assessment: The change of the subjects´erythema of a selected target plaque from baseline to the last visit	The results will be summarized as number and percent by visit. Tables from baseline will be prepared for all timepoints	14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts
Efficacy assessment: The change of the subjects´ thickness of a selected target plaque from baseline to the last visit	The results will be summarized as number and percent by visit. Tables from baseline will be prepared for all timepoints	14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts

Collaborators and Investigators

• Sponsor: Affibody
• Investigators: Principal Investigator: Tooraj Raoof, MD, Encino Research Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 13, 2019
• Primary Completion (ACTUAL): September 22, 2020
• Study Completion (ACTUAL): September 22, 2020

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (ACTUAL): July 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: ABY-035-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No