NCT07810777

Brief Summary

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)

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
12mo left

Started Sep 2026

Shorter than P25 for phase_2

Geographic Reach
2 countries

8 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Sep 2026Oct 2027

Study Start

First participant enrolled

September 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

September 3, 2026

Last Update Submit

September 3, 2026

Conditions

Atopic Dermatitis (AD)

Keywords

Inflammatory responsepharmacokineticspharmacodynamicsimmunogenicity

Outcome Measures

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)

    Up to 28 weeks

Secondary Outcomes (7)

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

    Up to 24 weeks

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

    Up to 24 weeks

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

    Up to 24 weeks

  • Pharmacokinetics of PRA-216: Tmax in patients with AD

    Up to 28 weeks

  • Pharmacokinetics of PRA-216: AUC in patients with AD

    Up to 28 weeks

  • +2 more secondary outcomes

Study Arms (2)

Active PRA-216

ACTIVE COMPARATOR

Participants with moderate to severe AD will be randomized to receive PRA-216

Drug: Active PRA-216

Placebo

PLACEBO COMPARATOR

Participants with moderate to severe AD will be randomized to receive placebo

Drug: Placebo

Interventions

Active PRA-216DRUG

biologic

Active PRA-216
PlaceboDRUG

matching placebo for PRA-216

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • History of inadequate response to topical medications for AD

You may not qualify if:

  • 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
  • Receipt of antibody therapy within 4 months or 5 half-lives
  • Other investigational agent(s) within 30 days or 5 half-lives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Emeritus Sydney

Botany, New South Wales, 2019, Australia

Location

Cornerstone Centre for Clinical Research

Coorparoo, Queensland, 4151, Australia

Location

Emeritus Melbourne

Camberwell, Victoria, 3124, Australia

Location

Momentum Sunshine

Melbourne, Victoria, 3021, Australia

Location

Optimal Clinical Trials (North)

Auckland, 0627, New Zealand

Location

Aotearoa Clinical Trials

Auckland, 2025, New Zealand

Location

Momentum Christchurch

Christchurch, 8013, New Zealand

Location

Clinical Trials New Zealand

Hamilton, 3204, New Zealand

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 9, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

September 9, 2026

Record last verified: 2026-09

Locations

AU(4)NZ(4)