MedTrace Logo

Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis

NCT03568162 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2022-08-23

Study results available
· View outcomes & findings →

Summary

Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a 16 week blinded treatment period.

Conditions

  • Moderate to Severe Atopic Dermatitis

Interventions

DRUG

ISB 830 - Part 1 Group 1

Subcutaneous injection (SC) every 2 weeks

DRUG

ISB 830 - Part 1 Group 2

Subcutaneous injection (SC) every 2 weeks

DRUG

ISB 830 - Part 1 Group 3

Subcutaneous injection (SC) every 2 weeks

DRUG

Placebo - Part 1 Group 4

Subcutaneous injection (SC) every 2 weeks

DRUG

ISB 830 - Part 2 Group 5

Subcutaneous injection (SC) every 2 weeks

DRUG

Placebo - Part 2 Group 6

Subcutaneous injection (SC) every 2 weeks

Sponsors & Collaborators

  • Glenmark Pharmaceuticals S.A.

    collaborator INDUSTRY

  • Ichnos Sciences SA

    lead INDUSTRY

Principal Investigators

  • Andrea Acocella, MD, MBA · Ichnos Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2020-08-11
Completion
2021-08-03
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03568162 on ClinicalTrials.gov