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NCT01855880 · ClinicalTrials.gov registry record · Phase 2

Phase IIa Study of Multiple Doses of AbGn-168H by iv Infusion in Moderate to Severe Chronic Plaque Psoriasis Patients

A Phase 2 study of Moderate-to-severe Chronic Plaque Psoriasis, sponsored by AbGenomics B.V Taiwan Branch.

Completed
Registry status
Phase 2
Development phase
54
Enrollment target
15
Study locations

NCT01855880: Completed Phase 2 study of Moderate-to-severe Chronic Plaque Psoriasis, sponsored by AbGenomics B.V Taiwan Branch.

NCT01855880 is a Phase 2 study of Moderate-to-severe Chronic Plaque Psoriasis that has completed, run by AbGenomics B.V Taiwan Branch. The registered enrollment target is 54 participants, below the 210-participant average among 3 other Moderate-to-severe Chronic Plaque Psoriasis trials with a reported enrollment target (74% lower). The trial reports 15 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01855880, a Phase 2 study of Moderate-to-severe Chronic Plaque Psoriasis, has completed, sponsored by AbGenomics B.V Taiwan Branch.

COMPLETED
Registry status
Phase 2
Development phase
54 participants
Enrollment target
15
Study locations

Study Summary

This is a Phase IIa, randomised, double-blind, placebo-controlled, multiple dose, multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis.The objectives of this study is to investigate efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients with moderate to severe chronic plaque psoriasis.

Primary Outcome

The primary objective of this study is to investigate efficacy (clinical proof of concept) of AbGn-168H in patients with moderate to severe chronic plaque psoriasis following intravenous administration of multiple doses compared to placebo. In this trial, the high dose and low dose of AbGn-168 and placebo is administered weekly.

Interventions

  • BIOLOGICAL placebo
  • BIOLOGICAL AbGn-168H

Study Locations (15)

Florida

  • Visions Clinical Research - Boynton Beach
  • Renstar Medical Research - Ocala
  • Progressive Medical Research - Orange
  • Olympian Clinical Research - Tampa

Arkansas

  • Baptist Health Certer for Clinical Research - Little Rock
  • Northwest AR Clinical Trials - Rogers

Indiana

  • DawesFretzin Clinical Research Group, LLC. - Indianaopoli
  • Indiana University Dermatology - Indianapolis

New York

  • University Urology Associates & Manhattan Research Associates - New York
  • Mount Sinai School of Medicine - New York

New Jersey

  • Comprehensive Clinical Research - Berlin

Oklahoma

  • Research Affiliation - Oklahoma City

South Carolina

  • Radiant Research, Inc. - Greer

Texas

  • Suzanne Bruce and Associates, The Center for Skin Research - Huston

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2013-05
Est. Completion 2014-03
Phase Phase 2
AbGenomics B.V Taiwan Branch

6 total trials

What the finished NCT01855880 record still lists

NCT01855880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 210-participant average among 3 other Moderate-to-severe Chronic Plaque Psoriasis trials with a reported enrollment target (74% lower).

The record links to 1 condition, with Moderate-to-severe Chronic Plaque Psoriasis appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT01855880 lists 15 locations in 9 states (Florida, Arkansas, Indiana).

Frequently Asked Questions

What is clinical trial NCT01855880 about?

NCT01855880 is a clinical study titled "Phase IIa Study of Multiple Doses of AbGn-168H by iv Infusion in Moderate to Severe Chronic Plaque Psoriasis Patients". This is a Phase IIa, randomised, double-blind, placebo-controlled, multiple dose, multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis.The objectives of this study is to investigate efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple doses of...

What is the current status of trial NCT01855880?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2013-05. Estimated completion is 2014-03.

What conditions does trial NCT01855880 study?

This clinical trial studies the following conditions: Moderate-to-severe Chronic Plaque Psoriasis.

What interventions are being tested in trial NCT01855880?

The interventions under investigation include: placebo (BIOLOGICAL), AbGn-168H (BIOLOGICAL).

Who is sponsoring clinical trial NCT01855880?

This trial is sponsored by AbGenomics B.V Taiwan Branch, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01855880 being conducted?

This trial has 15 study locations across Arkansas, Florida, Indiana, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01855880, the US trial registry maintained by the National Library of Medicine. NCT01855880 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.