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Monoclonal Antibodies

ISB 830 - Part 1 Group 3 for Eczema

Phase 2
Waitlist Available
Research Sponsored by Ichnos Sciences SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose (within 15 minutes prior to dose), 4, 24, 96, 120, 168, and 336 hours postdose on day 1 and predose (within 15 minutes prior to dose), and at 4, 24, 96, 120, 168 hours postdose on day 85
Awards & highlights

Study 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.

Eligible Conditions
  • Eczema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose (within 15 minutes prior to dose), 4, 24, 96, 120, 168, and 336 hours postdose on day 1 and predose (within 15 minutes prior to dose), 4, 24, 96, 120, and 168 hours postdose on day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose (within 15 minutes prior to dose), 4, 24, 96, 120, 168, and 336 hours postdose on day 1 and predose (within 15 minutes prior to dose), 4, 24, 96, 120, and 168 hours postdose on day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Clinical Score at Week 16
Secondary outcome measures
Area Under Curve From Time Zero to the End of Dosing Interval (AUC0-tau)
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Change From Baseline in Global Individual Signs Score (GISS) at Week 16
+12 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: ISB 830 - Part 2 Group 5Experimental Treatment1 Intervention
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830.
Group II: ISB 830 - Part 1 Group 3Experimental Treatment1 Intervention
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830 or placebo.
Group III: ISB 830 - Part 1 Group 2Experimental Treatment1 Intervention
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830 or placebo.
Group IV: ISB 830 - Part 1 Group 1Experimental Treatment1 Intervention
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830.
Group V: Placebo - Part 1 Group 4Placebo Group1 Intervention
Subcutaneous (SC) administration of placebo, followed by SC maintenance dose of placebo.
Group VI: Placebo - Part 2 Group 6Placebo Group1 Intervention
Subcutaneous (SC) administration of placebo, followed by SC maintenance dose of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ISB 830 - Part 1 Group 1
2018
Completed Phase 2
~470
ISB 830 - Part 1 Group 2
2018
Completed Phase 2
~470
ISB 830 - Part 1 Group 3
2018
Completed Phase 2
~470
ISB 830 - Part 2 Group 5
2018
Completed Phase 2
~470

Find a Location

Who is running the clinical trial?

Ichnos Sciences SALead Sponsor
6 Previous Clinical Trials
547 Total Patients Enrolled
1 Trials studying Eczema
64 Patients Enrolled for Eczema
Glenmark Pharmaceuticals S.A.Industry Sponsor
13 Previous Clinical Trials
1,941 Total Patients Enrolled
1 Trials studying Eczema
64 Patients Enrolled for Eczema
Andrea Acocella, MD, MBAStudy DirectorIchnos Sciences

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis
2018. "Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03568162.
~68 spots leftby Apr 2025
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