NCT07527923
Not yet recruiting
Phase 1
A Two-Part Phase 1, Randomized, Double-Blind, Placebo-Controlled First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN20423 in Adult Healthy Participants and Adult Participants With Atopic Dermatitis
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 136
- Primary Endpoint
- Occurrence of Treatment Emergent Adverse Events (TEAEs)
Overview
Brief Summary
This clinical trial will evaluate REGN20423, an investigational medicine that has not previously been studied in humans and is used only in clinical studies. The study will assess the safety, how the body processes the medicine, and the dose levels that may work best. It will also test whether REGN20423 can help treat adults with atopic dermatitis.
This is a two-part study:
Part A includes healthy adult participants. Part B includes adults with atopic dermatitis.
The Study is Looking at:
- What side effects REGN20423 might cause
- How much REGN20423 is in the blood at different times
- How well REGN20423 works in adults with atopic dermatitis
- Whether the body makes antibodies against REGN20423
- How the body changes after having REGN20423, which can help researchers understand why REGN20423 works better in some people than others
- What the best dose of REGN20423 is
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis
- •Key Inclusion Criteria:
- •Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and laboratory safety testing at screening and prior to initial dose of study intervention
- •Has a BMI within 18 to 31 kg/m² (inclusive) at the screening visit
- •Has a history of AD for at least 6 months at screening
- •Has EASI score ≥5 at both the screening and baseline visits
- •Has IGA score ≥2 at both the screening and baseline visits
Exclusion Criteria
- •Hospitalized (\>24 hours) for any reason within 30 days prior to the screening visit
- •Hypersensitivity to the study treatment or any of its excipients
- •History of clinical parasite infection, except treated trichomoniasis
- •Received a live attenuated vaccine within 1 month prior to the first screening visit or anticipates need for a live attenuated vaccine during the study
- •History of alcohol or drug abuse as determined by the investigator
- •Known or suspected history of immunosuppression
- •Presence of skin comorbidities at screening that may interfere with study assessments
- •Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list
- •Uncontrolled chronic disease that might require bursts of oral corticosteroids during the study
- •Note: Other protocol defined Inclusion/ Exclusion criteria apply
Arms & Interventions
Part A
Experimental
Intervention: REGN20423 (Drug)
Part A
Experimental
Intervention: Placebo (Other)
Part B
Experimental
Intervention: REGN20423 (Drug)
Part B
Experimental
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 52 weeks
Severity of TEAEs
Time Frame: Up to 52 weeks
Secondary Outcomes
- Percent change from baseline of total TARC(Up to 52 weeks)
- Occurrence of Anti-Drug Antibodies (ADA) to REGN20423(Up to 52 weeks)
- Magnitude of ADA to REGN20423(Up to 52 weeks)
- Percent change in EASI(From baseline up to 52 weeks)
- Absolute values from baseline of total eosinophil counts in blood(Up to 52 weeks)
- Absolute values from baseline of total periostin(Up to 52 weeks)
- Absolute values from baseline of total Thymus and Activation-Regulated Chemokine (TARC)(Up to 52 weeks)
- Percent change from baseline of total IL-13(Up to 52 weeks)
- Concentrations of REGN20423 in serum(Up to 52 weeks)
- Absolute values from baseline of total Interleukin 13 (IL-13)(Up to 52 weeks)
- Absolute values from baseline of total Immunoglobulin E (IgE)(Up to 52 weeks)
- Percent change from baseline of total IgE(Up to 52 weeks)
- Percent change from baseline of total eosinophil counts in blood(Up to 52 weeks)
- Percent change from baseline of total periostin(Up to 52 weeks)
- Absolute change from baseline in Eczema Area and Severity Index (EASI) score(Up to 52 weeks)
- Percent change from baseline in EASI score(Up to 52 weeks)
- Achievement of EASI-50(Up to 52 weeks)
- Achievement of EASI-75(Up to 52 weeks)
- Achievement of EASI-90(Up to 52 weeks)
- Achievement of Investigator's Global Assessment (IGA) 0-1(Up to 52 weeks)
- Achievement of IGA 0-1 with reduction in IGA score by ≥2(Up to 52 weeks)
- Achievement of a reduction in IGA score by ≥2(Up to 52 weeks)
- Absolute change in % Body Surface Area (BSA)(From baseline up to 52 weeks)
- Absolute change in EASI(From baseline up to 52 weeks)
- Percent change in % BSA(From baseline up to 52 weeks)
Investigators
Similar Trials
Not yet recruiting
Phase 2
Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary AdenocarcinomaNCT07314216Hunan Cancer Hospital15
Not yet recruiting
Phase 2
Glofitamab as a Bridge to and/or Consolidation Post Autologous Stem Cell Transplant in Patients With Relapsed B Cell LymphomasNCT07387848American University of Beirut Medical Center40
Not yet recruiting
Phase 3
A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast CancerHER2-positive Breast CancerNCT07518173Sichuan Baili Pharmaceutical Co., Ltd.596
Not yet recruiting
Phase 2
Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12C-Mutant NSCLC (GIVEN Study)NCT07472478Guangdong Provincial People's Hospital32
Recruiting
Phase 2
A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLCNCT07264816Sichuan Baili Pharmaceutical Co., Ltd.80