Status:
TERMINATED
Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis
Lead Sponsor:
Aptevo Therapeutics
Conditions:
Psoriasis
Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Phase 1 study in 2 stages with 2 expansion cohorts. The first stage is a single ascending dose (SAD) study of APVO210 in healthy volunteers. The second stage is a multiple ascending dose (MAD) study o...
Eligibility Criteria
Inclusion
- Main
- Age 18 to 65 years old.
- Body mass index (BMI) \> 18.5 kg/m2 and \< 30.0 kg/m2; minimum body weight of 50 kg.
- Good health and no clinically significant findings on:
- Physical examination
- 12-lead ECG
- Clinical laboratory tests (serum chemistry, haematology, coagulation, urine drug screen, and urinalysis (UA))
- Seated systolic blood pressure (BP) 90 to 140 mm Hg.
- Seated diastolic BP 60 to 90 mm Hg.
- Psoriasis Patients (Expansion Cohort):
- Main
- Clinical diagnosis of chronic plaque psoriasis with a disease duration of at least 6 months; patients with concurrent psoriatic arthritis may be enrolled.
- Psoriasis Area and Severity Index (PASI) score ≥ 12 at baseline.
- Psoriasis plaque BSA (Body surface area) ≥ 10%
- PGA (Physician Global Assessment) ≥ 3.
- Age 18 to 65 years old.
- Body mass index \> 18.5 and \< 35.0 kg/m2; minimum body weight of 50 kg.
- Ulcerative Colitis Patients (Expansion Cohort):
- Main
- Moderately to severely active ulcerative colitis as defined by:
- Baseline Mayo Score of 6 to 12; and
- Endoscopic sub-score ≥2 as read by central reader
- Is intolerant, refractory, or only partially responsive to corticosteroids (not including budesonide), immunomodulators (azathioprine \[AZA\] or 6-mercaptopurine \[6-MP\], and methotrexate), or biologics.
- Age 18 to 65 years old.
- Body mass index \> 18.5 and \< 35.0 kg/m2; minimum body weight of 50 kg.
Exclusion
- Main Exclusion Criteria
- Clinically significant manifestation of metabolic; hepatic; renal; haematological; pulmonary; cardiovascular; gastrointestinal; musculoskeletal; dermatological; urogenital; eye, ear, nose, and throat; psychiatric; or neurological disorders.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.2 times the upper limit of normal (ULN) as defined by the laboratory.
- Positive hepatitis panel (hepatitis B surface antigen \[HBsAg\] and anti-hepatitis C virus \[HCV\]) or positive human immunodeficiency virus (HIV) antibody.
- Positive Quantiferon tuberculosis (TB) test at Screening Visit.
- Receipt of live vaccine less than 1 month prior to Check in or plan to receive live vaccine during the study or up to 3 months following End of Treatment visit.
- Infection in the 4 weeks prior to Check-in that required hospitalization or parenteral antibiotics.
- Psoriasis Patients (Expansion Cohort):
- Main
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT03768219
Start Date
March 18 2019
End Date
June 30 2020
Last Update
May 19 2021
Active Locations (1)
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1
Nucleus Network
Melbourne, Victoria, Australia, 3004