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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03768219




Registration number
NCT03768219
Ethics application status
Date submitted
30/11/2018
Date registered
7/12/2018

Titles & IDs
Public title
Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis
Scientific title
Phase 1 Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis
Secondary ID [1] 0 0
8001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - APVO210
Treatment: Other - Placebo

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


Treatment: Other: APVO210
APVO210

Treatment: Other: Placebo
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with adverse events
Timepoint [1] 0 0
up to Day 29
Primary outcome [2] 0 0
Number of subjects with clinically relevant findings in vital signs
Timepoint [2] 0 0
up to Day 29
Primary outcome [3] 0 0
Number of subjects with significant changes from baseline laboratory measurements
Timepoint [3] 0 0
up to Day 29
Primary outcome [4] 0 0
Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results
Timepoint [4] 0 0
up to Day 29
Primary outcome [5] 0 0
Number of subjects with clinical significant abnormalities found on physical examination
Timepoint [5] 0 0
up to Day 29
Primary outcome [6] 0 0
Number of subjects with adverse events
Timepoint [6] 0 0
up to Day 57
Primary outcome [7] 0 0
Number of subjects with clinically relevant findings in vital signs
Timepoint [7] 0 0
up to Day 57
Primary outcome [8] 0 0
Number of subjects with significant changes from baseline laboratory measurements
Timepoint [8] 0 0
up to Day 57
Primary outcome [9] 0 0
Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results
Timepoint [9] 0 0
up to Day 57
Primary outcome [10] 0 0
Number of subjects with clinical significant abnormalities found on physical examination
Timepoint [10] 0 0
up to Day 57
Primary outcome [11] 0 0
Number of psoriasis patients with adverse events
Timepoint [11] 0 0
up to day 141
Primary outcome [12] 0 0
Number of psoriasis patients with clinically relevant findings in vital signs
Timepoint [12] 0 0
up to day 141
Primary outcome [13] 0 0
Number of psoriasis patients with significant changes from baseline laboratory measurements
Timepoint [13] 0 0
up to day 141
Primary outcome [14] 0 0
Number of psoriasis patients with clinically significant abnormalities in electrocardiogram (ECG) results
Timepoint [14] 0 0
up to day 141
Primary outcome [15] 0 0
Number of psoriasis patients with clinical significant abnormalities found on physical examination
Timepoint [15] 0 0
up to day 141
Primary outcome [16] 0 0
Number of ulcerative colitis patients with adverse events
Timepoint [16] 0 0
up to day 141
Primary outcome [17] 0 0
Number of ulcerative colitis patients with clinically relevant findings in vital signs
Timepoint [17] 0 0
up to day 141
Primary outcome [18] 0 0
Number of ulcerative colitis patients with significant changes from baseline laboratory measurements
Timepoint [18] 0 0
up to day 141
Primary outcome [19] 0 0
Number of ulcerative colitis patients with clinically significant abnormalities in electrocardiogram (ECG) results
Timepoint [19] 0 0
up to day 141
Primary outcome [20] 0 0
Number of ulcerative colitis patients with clinical significant abnormalities found on physical examination
Timepoint [20] 0 0
up to day 141
Secondary outcome [1] 0 0
The number of subjects who develop anti-drug antibodies to APVO210
Timepoint [1] 0 0
Up to day 29
Secondary outcome [2] 0 0
The number of subjects who develop anti-drug antibodies to APVO210
Timepoint [2] 0 0
Up to day 57
Secondary outcome [3] 0 0
The number of psoriasis patients who develop anti-drug antibodies to APVO210
Timepoint [3] 0 0
Up to day 141
Secondary outcome [4] 0 0
The number of ulcerative colitis patients who develop anti-drug antibodies to APVO210
Timepoint [4] 0 0
Up to day 141
Secondary outcome [5] 0 0
Serum level of Peak Plasma Concentration (Cmax)
Timepoint [5] 0 0
Up to day 29
Secondary outcome [6] 0 0
Serum level of Peak Plasma Concentration (Cmax)
Timepoint [6] 0 0
Up to day 57
Secondary outcome [7] 0 0
Serum level of Peak Plasma Concentration (Cmax) in psoriasis patients
Timepoint [7] 0 0
Up to day 141
Secondary outcome [8] 0 0
Serum level of Peak Plasma Concentration (Cmax) in ulcerative colitis patients
Timepoint [8] 0 0
Up to day 141
Secondary outcome [9] 0 0
Area under the plasma concentration versus time curve (AUC)
Timepoint [9] 0 0
Up to day 29
Secondary outcome [10] 0 0
Area under the plasma concentration versus time curve (AUC)
Timepoint [10] 0 0
Up to day 57
Secondary outcome [11] 0 0
Area under the plasma concentration versus time curve (AUC) for psoriasis patients
Timepoint [11] 0 0
Up to day 141
Secondary outcome [12] 0 0
Area under the plasma concentration versus time curve (AUC) for ulcerative colitis patients
Timepoint [12] 0 0
Up to day 141
Secondary outcome [13] 0 0
Change in number of leukocytes by flow cytometry in psoriasis patients
Timepoint [13] 0 0
Up to day 141
Secondary outcome [14] 0 0
Change in number of leukocytes by flow cytometry in ulcerative colitis patients
Timepoint [14] 0 0
Up to day 141
Secondary outcome [15] 0 0
Change in cytokine levels by ex-vivo LPS stimulation assay in psoriasis patients.
Timepoint [15] 0 0
Up to day 141
Secondary outcome [16] 0 0
Change in cytokine levels by ex-vivo LPS stimulation assay in ulcerative colitis patients.
Timepoint [16] 0 0
Up to day 141

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

* 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

* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2020
Sample size
Target
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Aptevo Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Schaaf, MD
Address 0 0
Aptevo Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03768219