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

NCT03580278 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ABY-035-101
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Subjects´ level of anti-drug antibodies (ADAs) in the blood

  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

  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

  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

  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

  14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts

Study Arms (2)

Cohort 1:75 mg ABY-035/AFO2

EXPERIMENTAL

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

Biological: ABY-035/AFO2

Cohort 2: 150 mg ABY-035/AFO2

EXPERIMENTAL

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

Biological: ABY-035/AFO2

Interventions

ABY-035/AFO2 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 1:75 mg ABY-035/AFO2; Cohort 2: 150 mg ABY-035/AFO2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Affibody: lead

Study Sites (1)

Raoof, Joseph

Encino, California, 16133, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tooraj Raoof, MD

  Encino Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: July 9, 2018
• Study Start: November 13, 2019
• Primary Completion: September 22, 2020
• Study Completion: September 22, 2020
• Last Updated: January 25, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)