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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03568162
Recruitment Status : Active, not recruiting
First Posted : June 26, 2018
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
Glenmark Pharmaceuticals S.A.
Information provided by (Responsible Party):
Ichnos Sciences SA

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.

Condition or disease Intervention/treatment Phase
Moderate to Severe Atopic Dermatitis Drug: ISB 830 - Part 1 Group 1 Drug: ISB 830 - Part 1 Group 2 Drug: ISB 830 - Part 1 Group 3 Drug: Placebo - Part 1 Group 4 Drug: ISB 830 - Part 2 Group 5 Drug: Placebo - Part 2 Group 6 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of ISB 830 in Adult Subjects With Moderate to Severe Atopic Dermatitis.
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: ISB 830 - Part 1 Group 1
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
Subcutaneous injection (SC) every 2 weeks

Experimental: ISB 830 - Part 1 Group 2
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
Subcutaneous injection (SC) every 2 weeks

Experimental: ISB 830 - Part 1 Group 3
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
Subcutaneous injection (SC) every 2 weeks

Placebo Comparator: Placebo - Part 1 Group 4
Subcutaneous (SC) administration of placebo, followed by SC maintenance dose of placebo.
Drug: Placebo - Part 1 Group 4
Subcutaneous injection (SC) every 2 weeks

Experimental: ISB 830 - Part 2 Group 5
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
Subcutaneous injection (SC) every 2 weeks

Placebo Comparator: Placebo - Part 2 Group 6
Subcutaneous (SC) administration of placebo, followed by SC maintenance dose of placebo.
Drug: Placebo - Part 2 Group 6
Subcutaneous injection (SC) every 2 weeks




Primary Outcome Measures :
  1. Percentage change from baseline in Eczema Area and Severity Index (EASI) score [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Proportion of subjects with Eczema Area and Severity Index (EASI-75) ie, ≥75% improvement from baseline [ Time Frame: 16 weeks ]
  2. Proportion of subjects with both IGA 0 or 1 (on a 5-point scale) and an IGA reduction from baseline of ≥2 points [ Time Frame: 16 weeks ]
  3. Proportion of subjects with improvement (reduction) of Pruritus Numerical Rating Scale (NRS) ≥4 from baseline [ Time Frame: 16 weeks ]
  4. Proportion of subjects who achieve an EASI 50 (≥50% improvement from baseline) response from baseline [ Time Frame: 16 weeks ]
  5. Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: 16 weeks ]
  6. Maximum Concentration (Cmax) of ISB 830 [ Time Frame: Week 1 and Week 12 ]
  7. Area Under Curve (AUC0-t) of ISB 830 [ Time Frame: Week 1 and Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects aged ≥18 years with physician diagnosis of atopic dermatitis for >1 year as defined by American Academy of Dermatology Consensus Criteria.
  • Atopic dermatitis involvement of ≥10% of body surface area at screening and baseline.
  • EASI score of ≥12 at screening or ≥16 at baseline.
  • IGA score of ≥3 at screening and baseline (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe)
  • Baseline Pruritus Numerical Rating Scale (NRS) score for maximum itch intensity ≥3 over the previous 24 hours.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Prior treatment with ISB 830
  • Treatment with biologics
  • Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy within 4 weeks of baseline
  • Active chronic or acute infection requiring systemic treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568162


Locations
Show Show 83 study locations
Sponsors and Collaborators
Ichnos Sciences SA
Glenmark Pharmaceuticals S.A.
Investigators
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Study Director: Andrea Acocella, MD, MBA Ichnos Sciences
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Responsible Party: Ichnos Sciences SA
ClinicalTrials.gov Identifier: NCT03568162    
Other Study ID Numbers: GBR 830-204
2018-000783-29 ( EudraCT Number )
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ichnos Sciences SA:
ISB 830, OX40, atopic dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases