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

Ichnos Sciences

Status and phase: Completed; Phase 2

Conditions: Moderate to Severe Atopic Dermatitis

Treatments: Drug: ISB 830 - Part 1 Group 3; Drug: ISB 830 - Part 1 Group 2; Drug: ISB 830 - Part 2 Group 5; Drug: ISB 830 - Part 1 Group 1; Drug: Placebo - Part 1 Group 4; Drug: Placebo - Part 2 Group 6

Study type: Interventional

Funder types: Industry

Identifiers

NCT03568162

2018-000783-29 (EudraCT Number)

GBR 830-204

Details and patient eligibility

About

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.

Enrollment: 462 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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462 participants in 6 patient groups, including a placebo group

ISB 830 - Part 1 Group 1

Experimental group

Description:

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

Treatment:

Drug: ISB 830 - Part 1 Group 1

ISB 830 - Part 1 Group 2

Experimental group

Description:

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

Treatment:

Drug: ISB 830 - Part 1 Group 2

ISB 830 - Part 1 Group 3

Experimental group

Description:

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

Treatment:

Drug: ISB 830 - Part 1 Group 3

Placebo - Part 1 Group 4

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo - Part 1 Group 4

ISB 830 - Part 2 Group 5

Experimental group

Description:

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

Treatment:

Drug: ISB 830 - Part 2 Group 5

Placebo - Part 2 Group 6

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo - Part 2 Group 6