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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ABY-035/AFO2

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Raoof, Joseph

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1:75 mg ABY-035/AFO2

Cohort 2: 150 mg ABY-035/AFO2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

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

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

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

Full Information

NCT ID

NCT03580278

First Posted

May 31, 2018

Last Updated

January 24, 2022

Sponsor

Affibody

1. Study Identification

Unique Protocol Identification Number

NCT03580278

Brief Title

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

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

November 13, 2019 (Actual)

Primary Completion Date

September 22, 2020 (Actual)

Study Completion Date

September 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Affibody

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1:75 mg ABY-035/AFO2

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 2: 150 mg ABY-035/AFO2

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

ABY-035/AFO2

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of subjects with treatment-related Adverse Events as assessed by the principles of Common Terminology Criteria for Adverse Events (CTCAE)

Description

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

Time Frame

28 Days

Title

Number of subjects with treatment-related Adverse Events as assessed by the principles of Common Terminology Criteria for Adverse Events (CTCAE)

Description

20 male and female psoriasis subjects will be enrolled to obtain who complete treatment or drop out due to adverse events for Cohort 3

Time Frame

42 Days

Secondary Outcome Measure Information:

Title

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

Description

To assess the immunogenicity of ABY-035 after multiple doses of ABY 035/AFO2 in psoriasis subjects

Time Frame

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

Title

If subjects have assessable pharmacokinetics (PK) of ABY-035

Description

To investigate the peak plasma concentration (Cmax ) of ABY-035 after multiple doses of ABY-035/AFO2 in psoriasis subjects

Time Frame

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

Title

If subjects have assessable pharmacokinetics (PK) of ABY-035

Description

To investigate the Area under the curve (AUC) versus time curve of ABY-035/AFO2 in psoriasis subjects

Time Frame

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

Title

Efficacy assessment: The change of the subjects´ scaling of a selected target plaque from baseline to the last visit

Description

The results will be summarized as number and percent by visit. Tables from baseline will be prepared for all timepoints

Time Frame

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

Title

Efficacy assessment: The change of the subjects´erythema of a selected target plaque from baseline to the last visit

Description

The results will be summarized as number and percent by visit. Tables from baseline will be prepared for all timepoints

Time Frame

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

Title

Efficacy assessment: The change of the subjects´ thickness of a selected target plaque from baseline to the last visit

Description

The results will be summarized as number and percent by visit. Tables from baseline will be prepared for all timepoints

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tooraj Raoof, MD

Organizational Affiliation

Encino Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Raoof, Joseph

City

Encino

State/Province

California

ZIP/Postal Code

16133

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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