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Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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 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

Exclusion Criteria:

  • - 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): Main

Exclusion Criteria:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03768219
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Aptevo Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 David Schaaf, MD
Principal Investigator Affiliation Aptevo Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis, Ulcerative Colitis
Arms & Interventions

Arms

Experimental: Stage 1 (SAD) Cohort 1

6 subjects will receive 2 mcg/kg of APVO210 2 subjects will receive placebo

Experimental: Stage 1 (SAD) Cohort 2

6 subjects will receive 5 mcg/kg of APVO210 2 subjects will receive placebo

Experimental: Stage 1 (SAD) Cohort 3

6 subjects will receive 10 mcg/kg of APVO210 2 subjects will receive placebo

Experimental: Stage 1 (SAD) Cohort 4

6 subjects will receive 20 mcg/kg of APVO210 2 subjects will receive placebo

Experimental: Stage 1 (SAD) Cohort 5

6 subjects will receive 40 mcg/kg of APVO210 2 subjects will receive placebo

Experimental: Stage 1 (SAD) Cohort 6

6 subjects will receive 80 mcg/kg of APVO210 2 subjects will receive placebo

Experimental: Stage 1 (SAD) Cohort 7

6 subjects will receive 160 mcg/kg of APVO210 2 subjects will receive placebo

Experimental: Stage 1 (SAD) Cohort 8

6 subjects will receive 320 mcg/kg of APVO210 2 subjects will receive placebo

Experimental: Stage 2 (MAD) Cohort 9

8 subjects will receive 40 mcg/kg of APVO210 2 subjects will receive placebo

Experimental: Stage 2 (MAD) Cohort 10

8 subjects will receive 80 mcg/kg of APVO210 2 subjects will receive placebo

Experimental: Stage 2 (MAD) Cohort 11

8 subjects will receive 160 mcg/kg of APVO210 2 subjects will receive placebo

Experimental: Stage 2 (MAD) Cohort 12

8 subjects will receive 360 mcg/kg of APVO210 2 subjects will receive placebo

Experimental: 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

Experimental: 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

Interventions

Biological: - APVO210

APVO210

Biological: - Placebo

Placebo is saline based IV infusion, and is identical in appearance to active study drug.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nucleus Network, Melbourne, Victoria, Australia

Status

Recruiting

Address

Nucleus Network

Melbourne, Victoria, 3004

Site Contact

Jason Lickliter, MD

j.lickliter@nucleusnetwork.com.au

03-8593-9800

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