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

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ClinicalTrials.gov Identifier: NCT03580278
Recruitment Status : Completed
First Posted : July 9, 2018
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
Affibody

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psoriasis Biological: ABY-035/AFO2 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 13, 2019
Actual Primary Completion Date : September 22, 2020
Actual Study Completion Date : September 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580278


Locations
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United States, California
Raoof, Joseph
Encino, California, United States, 16133
Sponsors and Collaborators
Affibody
Investigators
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Principal Investigator: Tooraj Raoof, MD Encino Research Center
More Information
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Responsible Party: Affibody
ClinicalTrials.gov Identifier: NCT03580278    
Other Study ID Numbers: ABY-035-101
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases