CClinicalTrials.gg
Sign In
TerminatedNCT03768219Updated May 19, 2021

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

A Phase 1 interventional study of APVO210 and Placebo in Psoriasis and Ulcerative Colitis, sponsored by Aptevo Therapeutics. Terminated at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-19.

Sponsored by Aptevo Therapeutics · Phase 1, Interventional, and Treatment

Why this study was terminated
Business decision
Phase
Phase 1
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis
  • Ulcerative Colitis
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 85 is above the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Aptevo Therapeutics is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
85 participants (actual)

Study arms

  • Experimental
    Stage 1 (SAD) Cohort 1

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

    Biological: APVO210 · Biological: Placebo

  • Experimental
    Stage 1 (SAD) Cohort 2

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

    Biological: APVO210 · Biological: Placebo

  • Experimental
    Stage 1 (SAD) Cohort 3

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

    Biological: APVO210 · Biological: Placebo

  • Experimental
    Stage 1 (SAD) Cohort 4

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

    Biological: APVO210 · Biological: Placebo

  • Experimental
    Stage 1 (SAD) Cohort 5

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

    Biological: APVO210 · Biological: Placebo

  • Experimental
    Stage 1 (SAD) Cohort 6

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

    Biological: APVO210 · Biological: Placebo

  • Experimental
    Stage 1 (SAD) Cohort 7

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

    Biological: APVO210 · Biological: Placebo

  • Experimental
    Stage 1 (SAD) Cohort 8

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

    Biological: APVO210 · Biological: Placebo

  • Experimental
    Stage 2 (MAD) Cohort 9

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

    Biological: APVO210 · Biological: Placebo

  • Experimental
    Stage 2 (MAD) Cohort 10

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

    Biological: APVO210 · Biological: Placebo

  • Experimental
    Stage 2 (MAD) Cohort 11

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

    Biological: APVO210 · Biological: Placebo

  • Experimental
    Stage 2 (MAD) Cohort 12

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

    Biological: APVO210 · Biological: 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

    Biological: APVO210 · Biological: 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

    Biological: APVO210 · Biological: Placebo

Interventions

  • BiologicalAPVO210

    APVO210

  • BiologicalPlacebo

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

06

What researchers measure

Primary outcomes

  1. Number of subjects with adverse events

    Time frame: up to Day 29

  2. Number of subjects with clinically relevant findings in vital signs

    Time frame: up to Day 29

  3. Number of subjects with significant changes from baseline laboratory measurements

    Time frame: up to Day 29

  4. Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results

    Time frame: up to Day 29

  5. Number of subjects with clinical significant abnormalities found on physical examination

    Time frame: up to Day 29

  6. Number of subjects with adverse events

    Time frame: up to Day 57

  7. Number of subjects with clinically relevant findings in vital signs

    Time frame: up to Day 57

  8. Number of subjects with significant changes from baseline laboratory measurements

    Time frame: up to Day 57

  9. Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results

    Time frame: up to Day 57

  10. Number of subjects with clinical significant abnormalities found on physical examination

    Time frame: up to Day 57

  11. Number of psoriasis patients with adverse events

    Time frame: up to day 141

  12. Number of psoriasis patients with clinically relevant findings in vital signs

    Time frame: up to day 141

  13. Number of psoriasis patients with significant changes from baseline laboratory measurements

    Time frame: up to day 141

  14. Number of psoriasis patients with clinically significant abnormalities in electrocardiogram (ECG) results

    Time frame: up to day 141

  15. Number of psoriasis patients with clinical significant abnormalities found on physical examination

    Time frame: up to day 141

  16. Number of ulcerative colitis patients with adverse events

    Time frame: up to day 141

  17. Number of ulcerative colitis patients with clinically relevant findings in vital signs

    Time frame: up to day 141

  18. Number of ulcerative colitis patients with significant changes from baseline laboratory measurements

    Time frame: up to day 141

  19. Number of ulcerative colitis patients with clinically significant abnormalities in electrocardiogram (ECG) results

    Time frame: up to day 141

  20. Number of ulcerative colitis patients with clinical significant abnormalities found on physical examination

    Time frame: up to day 141

Secondary outcomes

  1. The number of subjects who develop anti-drug antibodies to APVO210

    Time frame: Up to day 29

  2. The number of subjects who develop anti-drug antibodies to APVO210

    Time frame: Up to day 57

  3. The number of psoriasis patients who develop anti-drug antibodies to APVO210

    Time frame: Up to day 141

  4. The number of ulcerative colitis patients who develop anti-drug antibodies to APVO210

    Time frame: Up to day 141

  5. Serum level of Peak Plasma Concentration (Cmax)

    Time frame: Up to day 29

  6. Serum level of Peak Plasma Concentration (Cmax)

    Time frame: Up to day 57

  7. Serum level of Peak Plasma Concentration (Cmax) in psoriasis patients

    Time frame: Up to day 141

  8. Serum level of Peak Plasma Concentration (Cmax) in ulcerative colitis patients

    Time frame: Up to day 141

  9. Area under the plasma concentration versus time curve (AUC)

    Time frame: Up to day 29

  10. Area under the plasma concentration versus time curve (AUC)

    Time frame: Up to day 57

  11. Area under the plasma concentration versus time curve (AUC) for psoriasis patients

    Time frame: Up to day 141

  12. Area under the plasma concentration versus time curve (AUC) for ulcerative colitis patients

    Time frame: Up to day 141

  13. Change in number of leukocytes by flow cytometry in psoriasis patients

    Time frame: Up to day 141

  14. Change in number of leukocytes by flow cytometry in ulcerative colitis patients

    Time frame: Up to day 141

  15. Change in cytokine levels by ex-vivo LPS stimulation assay in psoriasis patients.

    Time frame: Up to day 141

  16. Change in cytokine levels by ex-vivo LPS stimulation assay in ulcerative colitis patients.

    Time frame: Up to day 141

07

Study locations

1 site
  • Nucleus Network
    Melbourne, Victoria 3004, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03768219
Lead sponsor
Aptevo Therapeutics
Responsible party
Sponsor
First posted
Dec 7, 2018
Start date
Mar 18, 2019
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Last update
May 19, 2021

Study contacts

David Schaaf, MD
principal investigator · Aptevo Therapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Colitis→

Other studies from this sponsor

Aptevo Therapeutics

Start the discussion