NCT03768219

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 18, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

1.3 years

First QC Date

November 30, 2018

Last Update Submit

May 15, 2021

Conditions

PsoriasisUlcerative Colitis

Outcome Measures

Primary Outcomes (20)

  • Number of subjects with adverse events

    up to Day 29

  • Number of subjects with clinically relevant findings in vital signs

    up to Day 29

  • Number of subjects with significant changes from baseline laboratory measurements

    up to Day 29

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

    up to Day 29

  • Number of subjects with clinical significant abnormalities found on physical examination

    up to Day 29

  • Number of subjects with adverse events

    up to Day 57

  • Number of subjects with clinically relevant findings in vital signs

    up to Day 57

  • Number of subjects with significant changes from baseline laboratory measurements

    up to Day 57

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

    up to Day 57

  • Number of subjects with clinical significant abnormalities found on physical examination

    up to Day 57

  • Number of psoriasis patients with adverse events

    up to day 141

  • Number of psoriasis patients with clinically relevant findings in vital signs

    up to day 141

  • Number of psoriasis patients with significant changes from baseline laboratory measurements

    up to day 141

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

    up to day 141

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

    up to day 141

  • Number of ulcerative colitis patients with adverse events

    up to day 141

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

    up to day 141

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

    up to day 141

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

    up to day 141

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

    up to day 141

Secondary Outcomes (16)

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

    Up to day 29

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

    Up to day 57

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

    Up to day 141

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

    Up to day 141

  • Serum level of Peak Plasma Concentration (Cmax)

    Up to day 29

  • +11 more secondary outcomes

Study Arms (14)

Stage 1 (SAD) Cohort 1

EXPERIMENTAL

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

Biological: APVO210Biological: Placebo

Stage 1 (SAD) Cohort 2

EXPERIMENTAL

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

Biological: APVO210Biological: Placebo

Stage 1 (SAD) Cohort 3

EXPERIMENTAL

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

Biological: APVO210Biological: Placebo

Stage 1 (SAD) Cohort 4

EXPERIMENTAL

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

Biological: APVO210Biological: Placebo

Stage 1 (SAD) Cohort 5

EXPERIMENTAL

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

Biological: APVO210Biological: Placebo

Stage 1 (SAD) Cohort 6

EXPERIMENTAL

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

Biological: APVO210Biological: Placebo

Stage 1 (SAD) Cohort 7

EXPERIMENTAL

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

Biological: APVO210Biological: Placebo

Stage 1 (SAD) Cohort 8

EXPERIMENTAL

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

Biological: APVO210Biological: Placebo

Stage 2 (MAD) Cohort 9

EXPERIMENTAL

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

Biological: APVO210Biological: Placebo

Stage 2 (MAD) Cohort 10

EXPERIMENTAL

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

Biological: APVO210Biological: Placebo

Stage 2 (MAD) Cohort 11

EXPERIMENTAL

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

Biological: APVO210Biological: Placebo

Stage 2 (MAD) Cohort 12

EXPERIMENTAL

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

Biological: APVO210Biological: 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

Biological: APVO210Biological: 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

Biological: APVO210Biological: Placebo

Interventions

APVO210BIOLOGICAL

APVO210

Expansion Cohort (Psoriasis)Expansion Cohort (Ulcerative Colitis)Stage 1 (SAD) Cohort 1Stage 1 (SAD) Cohort 2Stage 1 (SAD) Cohort 3Stage 1 (SAD) Cohort 4Stage 1 (SAD) Cohort 5Stage 1 (SAD) Cohort 6Stage 1 (SAD) Cohort 7Stage 1 (SAD) Cohort 8Stage 2 (MAD) Cohort 10Stage 2 (MAD) Cohort 11Stage 2 (MAD) Cohort 12Stage 2 (MAD) Cohort 9
PlaceboBIOLOGICAL

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

Expansion Cohort (Psoriasis)Expansion Cohort (Ulcerative Colitis)Stage 1 (SAD) Cohort 1Stage 1 (SAD) Cohort 2Stage 1 (SAD) Cohort 3Stage 1 (SAD) Cohort 4Stage 1 (SAD) Cohort 5Stage 1 (SAD) Cohort 6Stage 1 (SAD) Cohort 7Stage 1 (SAD) Cohort 8Stage 2 (MAD) Cohort 10Stage 2 (MAD) Cohort 11Stage 2 (MAD) Cohort 12Stage 2 (MAD) Cohort 9

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.
  • +7 more criteria

You may not qualify if:

  • 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):
  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

PsoriasisColitis, Ulcerative

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • David Schaaf, MD

    Aptevo Therapeutics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 7, 2018

Study Start

March 18, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

May 19, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)