A Study to Investigate the Safety, Tolerability, Pharmacokinetic, and Efficacy of ABY-035/AFO2
- Conditions
- Psoriasis
- Interventions
- Biological: ABY-035/AFO2
- Registration Number
- NCT03580278
- Lead Sponsor
- Affibody
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1:75 mg ABY-035/AFO2 ABY-035/AFO2 Cohort 1: 75 mg ABY-035/AFO2, once daily for 14 days Cohort 2: 150 mg ABY-035/AFO2 ABY-035/AFO2 Cohort 2: 150 mg ABY-035/AFO2 once daily for up to 28 days
- Primary Outcome Measures
Name Time Method Number of subjects with treatment-related Adverse Events as assessed by the principles of Common Terminology Criteria for Adverse Events (CTCAE) 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
Name Time Method If subjects have assessable pharmacokinetics (PK) of ABY-035 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´erythema of a selected target plaque from baseline to the last visit 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
Subjects´ level of anti-drug antibodies (ADAs) in the blood 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
Efficacy assessment: The change of the subjects´ scaling of a selected target plaque from baseline to the last visit 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 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
Trial Locations
- Locations (1)
Raoof, Joseph
🇺🇸Encino, California, United States