PsoriasisPhase 1NCT03768219
Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis
A Phase 1 study testing APVO210 in people with Psoriasis and Ulcerative Colitis, run by Aptevo Therapeutics at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Ulcerative Colitis
- What is being tested?
- APVO210
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Mar 2019to 30 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Psoriasis, Ulcerative Colitis
- Being tested
- APVO210, Placebo
- Medical subject headings
- Psoriasis, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APVO210Biological
APVO210
PlaceboBiological
Placebo is saline based IV infusion, and is identical in appearance to active study drug.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 (SAD) Cohort 1 | Experimental | 6 subjects will receive 2 mcg/kg of APVO210 2 subjects will receive placebo Receives: Biological: APVO210; Biological: Placebo |
| Stage 1 (SAD) Cohort 2 | Experimental | 6 subjects will receive 5 mcg/kg of APVO210 2 subjects will receive placebo Receives: Biological: APVO210; Biological: Placebo |
| Stage 1 (SAD) Cohort 3 | Experimental | 6 subjects will receive 10 mcg/kg of APVO210 2 subjects will receive placebo Receives: Biological: APVO210; Biological: Placebo |
| Stage 1 (SAD) Cohort 4 | Experimental | 6 subjects will receive 20 mcg/kg of APVO210 2 subjects will receive placebo Receives: Biological: APVO210; Biological: Placebo |
| Stage 1 (SAD) Cohort 5 | Experimental | 6 subjects will receive 40 mcg/kg of APVO210 2 subjects will receive placebo Receives: Biological: APVO210; Biological: Placebo |
| Stage 1 (SAD) Cohort 6 | Experimental | 6 subjects will receive 80 mcg/kg of APVO210 2 subjects will receive placebo Receives: Biological: APVO210; Biological: Placebo |
| Stage 1 (SAD) Cohort 7 | Experimental | 6 subjects will receive 160 mcg/kg of APVO210 2 subjects will receive placebo Receives: Biological: APVO210; Biological: Placebo |
| Stage 1 (SAD) Cohort 8 | Experimental | 6 subjects will receive 320 mcg/kg of APVO210 2 subjects will receive placebo Receives: Biological: APVO210; Biological: Placebo |
| Stage 2 (MAD) Cohort 9 | Experimental | 8 subjects will receive 40 mcg/kg of APVO210 2 subjects will receive placebo Receives: Biological: APVO210; Biological: Placebo |
| Stage 2 (MAD) Cohort 10 | Experimental | 8 subjects will receive 80 mcg/kg of APVO210 2 subjects will receive placebo Receives: Biological: APVO210; Biological: Placebo |
| Stage 2 (MAD) Cohort 11 | Experimental | 8 subjects will receive 160 mcg/kg of APVO210 2 subjects will receive placebo Receives: Biological: APVO210; Biological: Placebo |
| Stage 2 (MAD) Cohort 12 | Experimental | 8 subjects will receive 360 mcg/kg of APVO210 2 subjects will receive placebo Receives: Biological: APVO210; Biological: Placebo |
| Expansion Cohort (Psoriasis) | Experimental | 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 Receives: Biological: APVO210; Biological: Placebo |
| Expansion Cohort (Ulcerative Colitis) | Experimental | 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 Receives: Biological: APVO210; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: up to Day 29
Number of subjects with clinically relevant findings in vital signs
Measured: up to Day 29
Number of subjects with significant changes from baseline laboratory measurements
Measured: up to Day 29
Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results
Measured: up to Day 29
Number of subjects with clinical significant abnormalities found on physical examination
Measured: up to Day 29
Number of subjects with adverse events
Measured: up to Day 57
Number of subjects with clinically relevant findings in vital signs
Measured: up to Day 57
Number of subjects with significant changes from baseline laboratory measurements
Measured: up to Day 57
Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results
Measured: up to Day 57
Number of subjects with clinical significant abnormalities found on physical examination
Measured: up to Day 57
Number of psoriasis patients with adverse events
Measured: up to day 141
Number of psoriasis patients with clinically relevant findings in vital signs
Measured: up to day 141
Number of psoriasis patients with significant changes from baseline laboratory measurements
Measured: up to day 141
Number of psoriasis patients with clinically significant abnormalities in electrocardiogram (ECG) results
Measured: up to day 141
Number of psoriasis patients with clinical significant abnormalities found on physical examination
Measured: up to day 141
Number of ulcerative colitis patients with adverse events
Measured: up to day 141
Number of ulcerative colitis patients with clinically relevant findings in vital signs
Measured: up to day 141
Number of ulcerative colitis patients with significant changes from baseline laboratory measurements
Measured: up to day 141
Number of ulcerative colitis patients with clinically significant abnormalities in electrocardiogram (ECG) results
Measured: up to day 141
Number of ulcerative colitis patients with clinical significant abnormalities found on physical examination
Measured: up to day 141
Secondary outcomes (16)
The number of subjects who develop anti-drug antibodies to APVO210
Measured: Up to day 29
The number of subjects who develop anti-drug antibodies to APVO210
Measured: Up to day 57
The number of psoriasis patients who develop anti-drug antibodies to APVO210
Measured: Up to day 141
The number of ulcerative colitis patients who develop anti-drug antibodies to APVO210
Measured: Up to day 141
Serum level of Peak Plasma Concentration (Cmax)
Measured: Up to day 29
Serum level of Peak Plasma Concentration (Cmax)
Measured: Up to day 57
Serum level of Peak Plasma Concentration (Cmax) in psoriasis patients
Measured: Up to day 141
Serum level of Peak Plasma Concentration (Cmax) in ulcerative colitis patients
Measured: Up to day 141
Area under the plasma concentration versus time curve (AUC)
Measured: Up to day 29
Area under the plasma concentration versus time curve (AUC)
Measured: Up to day 57
Area under the plasma concentration versus time curve (AUC) for psoriasis patients
Measured: Up to day 141
Area under the plasma concentration versus time curve (AUC) for ulcerative colitis patients
Measured: Up to day 141
Change in number of leukocytes by flow cytometry in psoriasis patients
Measured: Up to day 141
Change in number of leukocytes by flow cytometry in ulcerative colitis patients
Measured: Up to day 141
Change in cytokine levels by ex-vivo LPS stimulation assay in psoriasis patients.
Measured: Up to day 141
Change in cytokine levels by ex-vivo LPS stimulation assay in ulcerative colitis patients.
Measured: Up to day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start18 Mar 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptevo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Schaaf, MD, Principal investigator, Aptevo Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768219
- Sponsor's protocol ID
- 8001
- Status last verified
- May 2021
- First submitted
- 30 Nov 2018
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03768219
- Acronym / sponsor ID
- 8001
- Conditions
- Psoriasis, Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Aptevo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
- 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
| Arm | Type | Receives |
|---|---|---|
| Stage 1 (SAD) Cohort 1 | Experimental | Biological: APVO210, Biological: Placebo6 subjects will receive 2 mcg/kg of APVO210 2 subjects will receive placebo |
| Stage 1 (SAD) Cohort 2 | Experimental | Biological: APVO210, Biological: Placebo6 subjects will receive 5 mcg/kg of APVO210 2 subjects will receive placebo |
| Stage 1 (SAD) Cohort 3 | Experimental | Biological: APVO210, Biological: Placebo6 subjects will receive 10 mcg/kg of APVO210 2 subjects will receive placebo |
| Stage 1 (SAD) Cohort 4 | Experimental | Biological: APVO210, Biological: Placebo6 subjects will receive 20 mcg/kg of APVO210 2 subjects will receive placebo |
| Stage 1 (SAD) Cohort 5 | Experimental | Biological: APVO210, Biological: Placebo6 subjects will receive 40 mcg/kg of APVO210 2 subjects will receive placebo |
| Stage 1 (SAD) Cohort 6 | Experimental | Biological: APVO210, Biological: Placebo6 subjects will receive 80 mcg/kg of APVO210 2 subjects will receive placebo |
| Stage 1 (SAD) Cohort 7 | Experimental | Biological: APVO210, Biological: Placebo6 subjects will receive 160 mcg/kg of APVO210 2 subjects will receive placebo |
| Stage 1 (SAD) Cohort 8 | Experimental | Biological: APVO210, Biological: Placebo6 subjects will receive 320 mcg/kg of APVO210 2 subjects will receive placebo |
| Stage 2 (MAD) Cohort 9 | Experimental | Biological: APVO210, Biological: Placebo8 subjects will receive 40 mcg/kg of APVO210 2 subjects will receive placebo |
| Stage 2 (MAD) Cohort 10 | Experimental | Biological: APVO210, Biological: Placebo8 subjects will receive 80 mcg/kg of APVO210 2 subjects will receive placebo |
| Stage 2 (MAD) Cohort 11 | Experimental | Biological: APVO210, Biological: Placebo8 subjects will receive 160 mcg/kg of APVO210 2 subjects will receive placebo |
| Stage 2 (MAD) Cohort 12 | Experimental | Biological: APVO210, Biological: Placebo8 subjects will receive 360 mcg/kg of APVO210 2 subjects will receive placebo |
| Expansion Cohort (Psoriasis) | Experimental | Biological: APVO210, Biological: Placebo12 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 |
| Expansion Cohort (Ulcerative Colitis) | Experimental | Biological: APVO210, Biological: Placebo12 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APVO210APVO210 | Biological | Expansion Cohort (Psoriasis), Expansion Cohort (Ulcerative Colitis), Stage 1 (SAD) Cohort 1, Stage 1 (SAD) Cohort 2, Stage 1 (SAD) Cohort 3, Stage 1 (SAD) Cohort 4, Stage 1 (SAD) Cohort 5, Stage 1 (SAD) Cohort 6, Stage 1 (SAD) Cohort 7, Stage 1 (SAD) Cohort 8, Stage 2 (MAD) Cohort 10, Stage 2 (MAD) Cohort 11, Stage 2 (MAD) Cohort 12, Stage 2 (MAD) Cohort 9 |
| PlaceboPlacebo is saline based IV infusion, and is identical in appearance to active study drug. | Biological | Expansion Cohort (Psoriasis), Expansion Cohort (Ulcerative Colitis), Stage 1 (SAD) Cohort 1, Stage 1 (SAD) Cohort 2, Stage 1 (SAD) Cohort 3, Stage 1 (SAD) Cohort 4, Stage 1 (SAD) Cohort 5, Stage 1 (SAD) Cohort 6, Stage 1 (SAD) Cohort 7, Stage 1 (SAD) Cohort 8, Stage 2 (MAD) Cohort 10, Stage 2 (MAD) Cohort 11, Stage 2 (MAD) Cohort 12, Stage 2 (MAD) Cohort 9 |
Primary outcome
Number of subjects with adverse events
Time frame: up to Day 29
Number of subjects with clinically relevant findings in vital signs
Time frame: up to Day 29
Number of subjects with significant changes from baseline laboratory measurements
Time frame: up to Day 29
Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results
Time frame: up to Day 29
Number of subjects with clinical significant abnormalities found on physical examination
Time frame: up to Day 29
Number of subjects with adverse events
Time frame: up to Day 57
Number of subjects with clinically relevant findings in vital signs
Time frame: up to Day 57
Number of subjects with significant changes from baseline laboratory measurements
Time frame: up to Day 57
Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results
Time frame: up to Day 57
Number of subjects with clinical significant abnormalities found on physical examination
Time frame: up to Day 57
Number of psoriasis patients with adverse events
Time frame: up to day 141
Number of psoriasis patients with clinically relevant findings in vital signs
Time frame: up to day 141
Number of psoriasis patients with significant changes from baseline laboratory measurements
Time frame: up to day 141
Number of psoriasis patients with clinically significant abnormalities in electrocardiogram (ECG) results
Time frame: up to day 141
Number of psoriasis patients with clinical significant abnormalities found on physical examination
Time frame: up to day 141
Number of ulcerative colitis patients with adverse events
Time frame: up to day 141
Number of ulcerative colitis patients with clinically relevant findings in vital signs
Time frame: up to day 141
Number of ulcerative colitis patients with significant changes from baseline laboratory measurements
Time frame: up to day 141
Number of ulcerative colitis patients with clinically significant abnormalities in electrocardiogram (ECG) results
Time frame: up to day 141
Number of ulcerative colitis patients with clinical significant abnormalities found on physical examination
Time frame: up to day 141
16 secondary outcomes
The number of subjects who develop anti-drug antibodies to APVO210
Time frame: Up to day 29
The number of subjects who develop anti-drug antibodies to APVO210
Time frame: Up to day 57
The number of psoriasis patients who develop anti-drug antibodies to APVO210
Time frame: Up to day 141
The number of ulcerative colitis patients who develop anti-drug antibodies to APVO210
Time frame: Up to day 141
Serum level of Peak Plasma Concentration (Cmax)
Time frame: Up to day 29
Serum level of Peak Plasma Concentration (Cmax)
Time frame: Up to day 57
Serum level of Peak Plasma Concentration (Cmax) in psoriasis patients
Time frame: Up to day 141
Serum level of Peak Plasma Concentration (Cmax) in ulcerative colitis patients
Time frame: Up to day 141
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to day 29
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to day 57
Area under the plasma concentration versus time curve (AUC) for psoriasis patients
Time frame: Up to day 141
Area under the plasma concentration versus time curve (AUC) for ulcerative colitis patients
Time frame: Up to day 141
Change in number of leukocytes by flow cytometry in psoriasis patients
Time frame: Up to day 141
Change in number of leukocytes by flow cytometry in ulcerative colitis patients
Time frame: Up to day 141
Change in cytokine levels by ex-vivo LPS stimulation assay in psoriasis patients.
Time frame: Up to day 141
Change in cytokine levels by ex-vivo LPS stimulation assay in ulcerative colitis patients.
Time frame: Up to day 141
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Schaaf, MD principal investigator
Aptevo Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APVO210 in people with Psoriasis and Ulcerative Colitis, run by Aptevo Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (time frame: up to Day 29). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.