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

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

Tracking Information

• First Submitted Date: May 31, 2018
• First Posted Date: July 9, 2018
• Last Update Posted Date: January 25, 2022
• Actual Study Start Date: November 13, 2019
• Actual Primary Completion Date: September 22, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 13, 2019)

• 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
• 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

Original Primary Outcome Measures (submitted: June 26, 2018)

• 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 ]
  10 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) [ 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

Current Secondary Outcome Measures (submitted: December 13, 2019)

• 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
• 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
• 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
• 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
• 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
• 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

Original Secondary Outcome Measures (submitted: June 26, 2018)

• Subjects´ level of anti-drug antibodies (ADAs) in the blood [ Time Frame: 14 Days dosing period for Cohorts 1 and 2, 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
• If subjects have assessable pharmacokinetics (PK) of ABY-035 [ Time Frame: 14 Days dosing period for Cohorts 1 and 2, 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
• If subjects have assessable pharmacokinetics (PK) of ABY-035 [ Time Frame: 14 Days dosing period for Cohorts 1 and 2, 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
• 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 Cohorts 1 and 2, 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
• 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 Cohorts 1 and 2, 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
• 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 Cohorts 1 and 2, 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

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

• Condition: Psoriasis

Intervention

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

Study Arms

• Experimental: Cohort 1:75 mg ABY-035/AFO2
  Cohort 1: 75 mg ABY-035/AFO2, once daily for 14 days
  Intervention: Biological: ABY-035/AFO2
• Experimental: Cohort 2: 150 mg ABY-035/AFO2
  Cohort 2: 150 mg ABY-035/AFO2 once daily for up to 28 days
  Intervention: Biological: ABY-035/AFO2

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 27, 2020): 33
• Original Estimated Enrollment (submitted: June 26, 2018): 30
• Actual Study Completion Date: September 22, 2020
• Actual Primary Completion Date: September 22, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03580278
• Other Study ID Numbers: ABY-035-101
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Affibody
• Original Responsible Party: Same as current
• Current Study Sponsor: Affibody
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tooraj Raoof, MD; Encino Research Center

• PRS Account: Affibody
• Verification Date: November 2020