Psoriasis, Ulcerative Colitis
Conditions
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 of APVO210 in healthy volunteers. Two expansion cohorts evaluate multiple doses of APVO210 in psoriasis patients and ulcerative colitis patients.
Interventions
BIOLOGICALAPVO210
APVO210
BIOLOGICALPlacebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Sponsors
Aptevo Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
SAD: Randomized, double-blind, placebo-controlled, sequential cohort-group study with a sentinel subject design MAD: Randomized, double-blind, placebo-controlled, sequential cohort-group study Psoriasis Expansion Cohort: Randomized, double-blind, placebo-controlled study Ulcerative Colitis Expansion Cohort: Randomized, double-blind, placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Main Inclusion Criteria: * 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 Inclusion Criteria: * 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 Inclusion Criteria: * 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 criteria
Main
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events | up to Day 29 |
| Number of subjects with clinically relevant findings in vital signs | up to Day 29 |
| Number of subjects with significant changes from baseline laboratory measurements | up to Day 29 |
| Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results | up to Day 29 |
| Number of subjects with clinical significant abnormalities found on physical examination | up to Day 29 |
| Number of psoriasis patients with adverse events | up to day 141 |
| Number of psoriasis patients with clinically relevant findings in vital signs | up to day 141 |
| Number of psoriasis patients with significant changes from baseline laboratory measurements | up to day 141 |
| Number of psoriasis patients with clinically significant abnormalities in electrocardiogram (ECG) results | up to day 141 |
| Number of psoriasis patients with clinical significant abnormalities found on physical examination | up to day 141 |
| Number of ulcerative colitis patients with adverse events | up to day 141 |
| Number of ulcerative colitis patients with clinically relevant findings in vital signs | up to day 141 |
| Number of ulcerative colitis patients with significant changes from baseline laboratory measurements | up to day 141 |
| Number of ulcerative colitis patients with clinically significant abnormalities in electrocardiogram (ECG) results | up to day 141 |
| Number of ulcerative colitis patients with clinical significant abnormalities found on physical examination | up to day 141 |
Secondary
| Measure | Time frame |
|---|---|
| The number of subjects who develop anti-drug antibodies to APVO210 | Up to day 29 |
| The number of psoriasis patients who develop anti-drug antibodies to APVO210 | Up to day 141 |
| The number of ulcerative colitis patients who develop anti-drug antibodies to APVO210 | Up to day 141 |
| Serum level of Peak Plasma Concentration (Cmax) | Up to day 29 |
| Serum level of Peak Plasma Concentration (Cmax) in psoriasis patients | Up to day 141 |
| Serum level of Peak Plasma Concentration (Cmax) in ulcerative colitis patients | Up to day 141 |
| Area under the plasma concentration versus time curve (AUC) | Up to day 29 |
| Area under the plasma concentration versus time curve (AUC) for psoriasis patients | Up to day 141 |
| Area under the plasma concentration versus time curve (AUC) for ulcerative colitis patients | Up to day 141 |
| Change in number of leukocytes by flow cytometry in psoriasis patients | Up to day 141 |
| Change in number of leukocytes by flow cytometry in ulcerative colitis patients | Up to day 141 |
| Change in cytokine levels by ex-vivo LPS stimulation assay in psoriasis patients. | Up to day 141 |
| Change in cytokine levels by ex-vivo LPS stimulation assay in ulcerative colitis patients. | Up to day 141 |
Countries
Australia
Outcome results
None listed