NCT04271514
Completed
Phase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Escalation, Multiple-dose Escalation, and Food Effect Study of RPT193 in Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis
ConditionsAtopic Dermatitis
Overview
- Phase
- Phase 1
- Intervention
- RPT193
- Conditions
- Atopic Dermatitis
- Sponsor
- RAPT Therapeutics, Inc.
- Enrollment
- 103
- Locations
- 14
- Primary Endpoint
- Incidence of Treatment Emergent Adverse Events
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study is a first-in-human, 3-part, multi-center, Phase 1, randomized, double-blind, placebo-controlled study with RPT193 in up to 64 healthy male and female subjects and 30 male and female patients with atopic dermatitis. RPT193 is an orally-available, potent, and selective antagonist of CCR4.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Parts A \& B (COMPLETED ENROLLMENT):
- •Healthy male or female
- •18-55 years of age, inclusive
- •At least 50 kg in weight
- •BMI: 18.0-30.0 kg/m2, inclusive
- •Part C (COMPLETED ENROLLMENT):
- •Male or female with atopic dermatitis
- •18-65 years of age, inclusive
- •BMI between 18.0 (inclusive) and \<40.0 kg/m2
- •Body surface area (BSA) with AD involvement ≥10%
Exclusion Criteria
- •Parts A \& B (COMPLETED ENROLLMENT):
- •Use of tobacco products within 60 days prior to drug administration
- •History of alcohol abuse or drug addiction
- •Positive drug and alcohol screen
- •Participation in a drug study within 60 days prior to drug administration
- •Donation or loss of more than 100 mL of blood within 60 days prior to drug administration.
- •Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to drug administration.
- •Part C (COMPLETED ENROLLMENT):
- •Any serious and/or uncontrolled medical condition
- •History of alcohol abuse or drug addiction
Arms & Interventions
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active
Increasing doses of RPT193 will be administered to healthy volunteers
Intervention: RPT193
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo
Matching placebo will be administered to healthy volunteers
Intervention: Placebo
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active
Increasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers
Intervention: RPT193
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo
Matching placebo will be administered once/day for 7 days to healthy volunteers
Intervention: Placebo
COMPLETED ENROLLMENT -- Expansion Part C - active
RPT193 will be administered daily for 28 days to patients with atopic dermatitis
Intervention: RPT193
COMPLETED ENROLLMENT -- Expansion Part C - placebo
Matching placebo will be administered daily for 28 days to patients with atopic dermatitis
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of Treatment Emergent Adverse Events
Time Frame: up to Day 16 (Part A: SAD); up to Day 22 (Part B: MAD); up to Day 43 (Part C)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Study Sites (14)
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Related News
RPT193 Shows Clinical Improvement in Atopic Dermatitis Patients- RPT193, an oral CCR4 antagonist, demonstrated greater improvements in clinical efficacy endpoints compared to placebo in adults with moderate to severe atopic dermatitis.
- The Phase 1 study highlighted that RPT193 was well-tolerated, with most treatment-emergent adverse events being mild to moderate across all cohorts.
- Patients receiving RPT193 400 mg QD showed numerically greater improvements in EASI, BSA, vIGA, and SCORAD scores compared to the placebo group over 28 days.
- Post-hoc analysis revealed statistically significant differences in efficacy endpoints at day 43, suggesting sustained efficacy beyond the treatment period.Oral CCR4 Antagonist RPT193 Shows Promise in Atopic Dermatitis Phase 1 Trial- RPT193, an oral CCR4 antagonist, was well-tolerated in healthy subjects and those with moderate-to-severe atopic dermatitis in a Phase 1 trial.
- Atopic dermatitis patients treated with RPT193 monotherapy showed numerically greater improvements in clinical efficacy endpoints compared to placebo by day 29.
- Statistically significant improvements in clinical efficacy were observed two weeks post-treatment (Day 43) in RPT193-treated subjects versus placebo.
- Skin biopsies from RPT193-treated subjects showed significant changes in transcriptional profiles correlated with clinical improvements.Rapt Therapeutics' RPT193 Faces Setback in Atopic Dermatitis Development• RAPT Therapeutics' RPT193 saw its Phase Transition Success Rate (PTSR) for atopic dermatitis decrease by 13 points to 78%, despite positive Phase Ib trial results.
• The Phase Ib trial data showed a 36.3% improvement from baseline in Eczema Area and Severity Index (EASI) score with RPT193, compared to 17% with placebo over four weeks.
• RPT193's Likelihood of Approval (LoA) also experienced a slight decrease of one point, settling at 3%, based on GlobalData's analysis.
• Rapt Therapeutics is planning to advance RPT193 into a Phase IIb trial for atopic dermatitis, with the drug targeting CCR4 on Th2 cells.