Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis
NCT ID: NCT03768219
Last Updated: 2021-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
85 participants
INTERVENTIONAL
2019-03-18
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
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
TREATMENT
QUADRUPLE
Study Groups
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Stage 1 (SAD) Cohort 1
6 subjects will receive 2 mcg/kg of APVO210 2 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Stage 1 (SAD) Cohort 2
6 subjects will receive 5 mcg/kg of APVO210 2 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Stage 1 (SAD) Cohort 3
6 subjects will receive 10 mcg/kg of APVO210 2 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Stage 1 (SAD) Cohort 4
6 subjects will receive 20 mcg/kg of APVO210 2 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Stage 1 (SAD) Cohort 5
6 subjects will receive 40 mcg/kg of APVO210 2 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Stage 1 (SAD) Cohort 6
6 subjects will receive 80 mcg/kg of APVO210 2 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Stage 1 (SAD) Cohort 7
6 subjects will receive 160 mcg/kg of APVO210 2 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Stage 1 (SAD) Cohort 8
6 subjects will receive 320 mcg/kg of APVO210 2 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Stage 2 (MAD) Cohort 9
8 subjects will receive 40 mcg/kg of APVO210 2 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Stage 2 (MAD) Cohort 10
8 subjects will receive 80 mcg/kg of APVO210 2 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Stage 2 (MAD) Cohort 11
8 subjects will receive 160 mcg/kg of APVO210 2 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Stage 2 (MAD) Cohort 12
8 subjects will receive 360 mcg/kg of APVO210 2 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Expansion Cohort (Psoriasis)
12 subjects will receive the starting dose for the Psoriasis Patients Expansion Cohort portion of the study will be the recommended dose from Stage 2 of the study of APVO210. It will be a dose that has been demonstrated to be safe and well tolerated by the Safety Monitoring Committee.
8 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Expansion Cohort (Ulcerative Colitis)
12 Subjects will receive the starting dose for the Ulcerative Colitis Patients Expansion Cohort portion of the study will be the recommended dose from Stage 2 of the study of APVO210. It will be a dose that has been demonstrated to be safe and well tolerated by the Safety Monitoring Committee.
8 subjects will receive placebo
APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Interventions
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APVO210
APVO210
Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Eligibility Criteria
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Inclusion Criteria
* 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):
* 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):
* 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
* 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):
* History of malignancy, diagnosed or known to be active or actively treated within the past 5 years, other than resected lesions of low malignant potential, such as basal cell skin cancers or low risk squamous cell carcinomas of the skin.
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the upper limit of normal (ULN) as defined by the laboratory.
* Creatinine \> 1.5 times 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.
* Use of a prescription medication that could have an effect on psoriasis (eg, lithium, systemic steroids, immunosuppressants) during the 14 days before Check-in; use of prescription medications for psoriasis is not permitted until after the Follow-up Visit.
* Non plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular).
* Use of biologic agents (eg, adalimumab, etanercept, infliximab, ustekinumab, ixekizumab, secukinumab, guselkumab, tildrakizumab, brodalumab) or psoralen and ultraviolet A (PUVA) within 12 weeks prior to Check-in, ultraviolet B (UVB) phototherapy, use of tanning beds, or use of systemic medications such as methotrexate, cyclosporine A, acitretin, tofacitinib or apremilast within 4 weeks prior to Check-in, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to Check-in.
Ulcerative Colitis Patients (Expansion Cohort):
* Ulcerative colitis requiring immediate surgical, endoscopic, or radiological intervention including massive haemorrhage, perforation and sepsis, suppurative complications, or toxic colon.
* Stool positive for Clostridium difficile toxin, enteric pathogens, or ova and parasites.
* 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.
* Use of biologic agents (eg, adalimumab, etanercept, infliximab, ustekinumab, ixekizumab, secukinumab, guselkumab, tildrakizumab, brodalumab) or psoralen and ultraviolet A (PUVA) within 12 weeks prior to Check-in, ultraviolet B (UVB) phototherapy, use of tanning beds, or use of systemic medications such as methotrexate, cyclosporine A, acitretin, tofacitinib or apremilast within 4 weeks prior to Check-in, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to Check-in.
18 Years
65 Years
ALL
Yes
Sponsors
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Aptevo Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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David Schaaf, MD
Role: PRINCIPAL_INVESTIGATOR
Aptevo Therapeutics
Locations
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Nucleus Network
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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8001
Identifier Type: -
Identifier Source: org_study_id
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