A Phase 1 interventional study of ABY-035/AFO2 in Psoriasis, sponsored by Affibody. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-01-25.
Sponsored by Affibody · Phase 1, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 33 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Affibody is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Cohort 1: 75 mg ABY-035/AFO2, once daily for 14 days
Biological: 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
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
Time frame: 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
Time frame: 42 Days
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
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
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
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
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
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
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
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
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
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
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
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
Plan to share: No
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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