An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis

RAPT Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: RPT193; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05399368

RPT193-02

Details and patient eligibility

About

Phase 2 study of RPT193 in adults with atopic dermatitis

Full description

Randomized, placebo-controlled Phase 2 study of RPT193 in adults with moderate-to-severe atopic dermatitis

Enrollment: 229 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically confirmed diagnosis of active atopic dermatitis (AD), according to the revised Hanifin and Rajka criteria
• 12-month history of AD and had no significant flares in AD for at least 4 weeks before screening
• inadequate response to a ≥1 month treatment with topical medications
• Atopic dermatitis covering ≥10% of the body surface area
• EASI score ≥16
• Validated Investigator Global Assessment (VIGA) ≥3
• Use of emollient(s) at least 2x daily for 1 week prior to baseline
• Negative coronavirus disease (COVID)-19 results at screening

Exclusion criteria

• Uncontrolled moderate-to-severe asthma
• Uncontrolled diabetes
• Stage III or IV cardiac failure
• Severe renal condition
• Major surgery within 8 weeks of screening
• Immunodeficiency and/or receipt of immunosuppressive drugs within 4 weeks of baseline
• Use of systemic Janus kinase (JAK) inhibitor within 8 weeks of baseline
• Received live or live-attenuated vaccine within 4 weeks of baseline
• Prior receipt of RPT193

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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229 participants in 4 patient groups, including a placebo group

RPT193 400 mg

Experimental group

Description:

RPT193 400 mg oral tablet administered daily for 16 weeks

Treatment:

Drug: RPT193

RPT193 200 mg

Experimental group

Description:

RPT193 200 mg oral tablet administered daily for 16 weeks

Treatment:

Drug: RPT193

RPT193 50 mg

Experimental group

Description:

RPT193 50 mg oral tablet administered daily for 16 weeks

Treatment:

Drug: RPT193

Placebo

Placebo Comparator group

Description:

Matching placebo oral tablet administered daily for 16 weeks

Treatment:

Other: Placebo