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Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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

NCT03768219•Aptevo Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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):
•Clinical diagnosis of chronic plaque psoriasis with a disease duration of at least 6 months; patients with concurrent psoriatic arthritis may be enrolled.
+12 more criteria

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):
•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.
+15 more criteria

Locations (1)

Nucleus Network

Melbourne, Victoria, Australia

Key Dates

Start Date

March 18, 2019

Primary Completion Date

June 30, 2020

Completion Date

June 30, 2020

Last Updated

May 19, 2021

Enrollment

ACTUAL participants

Conditions

PsoriasisUlcerative Colitis

Interventions

APVO210

BIOLOGICAL

Placebo

BIOLOGICAL

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

View study

RECRUITING

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

View study

RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis