Health Trials

PRA-216 Atopic Dermatitis Safety and Efficacy Study

ConditionAtopic Dermatitis (AD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPrana Therapies Inc

About this trial

This study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with moderate to severe Atopic Dermatitis (AD)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must be in good health with no significant medical history

Willing and able to attend all study visits, comply with study requirements.

Able and willing to provide written informed consent

Documented AD diagnosis prior for at least 6 months prior to enrollment.

Disqualifiers

Evidence of clinically significant skin condition or disease other than AD

Any physical or psychological condition that prohibits study completion

Known history of illicit drug use or alcoholism within 12 months prior to the first dose of study agent

History of severe allergic reactions or hypersensitivity

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active PRA-216

    Drug

    biologic

  • Placebo

    Drug

    matching placebo for PRA-216

Treatment groups

39 Participants
are divided into 2 treatment groups
Group A: Active PRA-216Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of PRA-216 in patients with moderate to severe atopic dermatitis (AD)

Time frame
Up to 28 weeks

Secondary outcomes

1

Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD

Mean percent change from baseline in Eczema Area and Severity Index (EASI). EASI is a score that will grade atopic dermatitis, with a higher number indicating more severe disease. A score of 0 indicates clear skin, and a score of 72 is severe disease.

Time frame
Up to 24 weeks
2

Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD: EASI-75

Percentage of patients achieving EASI-75. EASI-75 indicates a 75% improvement in severity and spread of skin lesions compared to baseline.

Time frame
Up to 24 weeks
3

Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD: EASI-90

Percentage of patients achieving EASI-90. EASI-90 indicates a 90% improvement in severity and spread of skin lesions compared to baseline.

Time frame
Up to 24 weeks
4

Pharmacokinetics of PRA-216: Tmax in patients with AD

Time to maximum concentration of drug in plasma

Time frame
Up to 28 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prana Therapies Inc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: