NCT03568162|CompletedPhase 2ResultsDMCFDA Drug

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of ISB 830 in Adult Subjects With Moderate to Severe Atopic Dermatitis.

Ichnos Sciences SA ClinicalTrials.gov

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2 other identifiers

GBR 830-2042018-000783-29

Study Type

interventional

Target

462

Locations

5 countries

Sites

Timeline

RegisteredJun 2018

StartedMay 2018

CompletionAug 2021

Brief 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.

Trial Health

On Track

Trial Health Score

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

Enrollment

462

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started May 2018

Typical duration for phase_2

Geographic Reach

5 countries

83 active sites

Status

completed

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

3.2 years study duration

First Submitted

Initial submission to the registry

May 31, 2018

Completed

Same day until next milestone

Study Start

First participant enrolled

May 31, 2018

Completed

26 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2020

Completed

12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2021

Completed

11 months until next milestone

Results Posted

Study results publicly available

June 28, 2022

Completed

Last Updated

August 23, 2022

Status Verified

July 1, 2022

Enrollment Period

2.2 years

First QC Date

May 31, 2018

Results QC Date

June 2, 2022

Last Update Submit

July 26, 2022

Conditions

Moderate to Severe Atopic Dermatitis

Keywords

ISB 830, OX40, atopic dermatitis

Outcome Measures

Primary Outcomes (1)

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Clinical Score at Week 16
In EASI, four disease characteristics of atopic dermatitis (AD) (erythema, edema/papulation, excoriation, and lichenification) are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the four body regions (Head and neck, trunk, arms, and legs). The assigned percentages of body surface area (BSA) for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs. Each subtotal score is multiplied by the BSA represented by that region. In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage of AD-affected skin in that area: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores are multiplied by the area affected. The resulting EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD.
Baseline, Week 16

Secondary Outcomes (15)

Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 16
Baseline, Week 16
Percentage of Participants Achieving Both Investigator's Global Assessment (IGA) Clinical Score of 0 or 1 and an IGA Reduction From Baseline of ≥ 2 Points at Week 16
Baseline, Week 16
Percentage of Participants With Improvement (Reduction) in Pruritus Numerical Rating Scale (NRS) Score of ≥ 4 From Baseline at Week 16
Baseline, Week 16
Percentage of Participants Achieving a 50% Reduction From Baseline in EASI Score (EASI-50) at Week 16
Baseline, Week 16
Percent Change From Baseline in SCORAD Score at Week 16
Baseline, Week 16
+10 more secondary outcomes

Study Arms (6)

ISB 830 - Part 1 Group 1

EXPERIMENTAL

Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830.

Drug: ISB 830 - Part 1 Group 1

ISB 830 - Part 1 Group 2

EXPERIMENTAL

Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830 or placebo.

Drug: ISB 830 - Part 1 Group 2

ISB 830 - Part 1 Group 3

EXPERIMENTAL

Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830 or placebo.

Drug: ISB 830 - Part 1 Group 3

Placebo - Part 1 Group 4

PLACEBO COMPARATOR

Subcutaneous (SC) administration of placebo, followed by SC maintenance dose of placebo.

Drug: Placebo - Part 1 Group 4

ISB 830 - Part 2 Group 5

EXPERIMENTAL

Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830.

Drug: ISB 830 - Part 2 Group 5

Placebo - Part 2 Group 6

PLACEBO COMPARATOR

Subcutaneous (SC) administration of placebo, followed by SC maintenance dose of placebo.

Drug: Placebo - Part 2 Group 6