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Completed

NCT Number: NCT03580278

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

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Raoof, Joseph

Encino, California, 16133, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 28 Days

    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

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

    Time frame: 42 Days

    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 outcomes

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

Sponsors and collaborators

Lead sponsor

Affibody

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 9, 2018
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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