NCT06554847

Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
3mo left

Started Sep 2024

Geographic Reach
1 country

3 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Sep 2024Aug 2026

First Submitted

Initial submission to the registry

August 12, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 23, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2026

Expected
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

1.1 years

First QC Date

August 12, 2024

Last Update Submit

July 11, 2025

Conditions

Dermatitis, AtopicEczema, Atopic

Outcome Measures

Primary Outcomes (2)

  • Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score)

    Baseline to Week 16

  • Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16.

    Baseline to Week 16

Secondary Outcomes (1)

  • Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16

    Baseline to Week 16

Study Arms (3)

611 interval 1+Topical Corticosteroid

EXPERIMENTAL

Participants will receive 611 according to established dosing interval 1. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.

Drug: 611Drug: Topical corticosteroid

611 interval 2+Topical Corticosteroid

EXPERIMENTAL

Participants will receive 611 according to established dosing interval 2. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.

Drug: 611Drug: Topical corticosteroid

Placebo+Topical Corticosteroid

PLACEBO COMPARATOR

Participants will receive Placebo according to according to established dosing intervals. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.

Drug: PlaceboDrug: Topical corticosteroid

Interventions

611DRUG

subcutaneous injection

611 interval 1+Topical Corticosteroid611 interval 2+Topical Corticosteroid
PlaceboDRUG

subcutaneous injection

Placebo+Topical Corticosteroid
Topical corticosteroidDRUG

Topical

611 interval 1+Topical Corticosteroid611 interval 2+Topical CorticosteroidPlacebo+Topical Corticosteroid

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female adults ages 18 to 75 years old when signing the informed consent.
  • AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit.
  • Moderate to Severe Atopic Dermatitis.
  • Recent history of inadequate response to treatment with topical medications.

You may not qualify if:

  • Participation in a prior 611 clinical study.
  • Treatment with the following prior to the baseline visit: 1) Systemic corticosteroid or Immunosuppressants / Immunomodulators within 4 weeks or within 5 half-lives (if known), whichever is longer. 2) Monoclonal antibody within 5 half-lives (if known) or 4 months, whichever is longer. 3) Cell-depleting within 6 months.
  • Treatment with a live (attenuated) vaccine within 2 months of the baseline visit or planned during the study.
  • Serious or Uncontrolled diseases that may affect the safety of participants during the study period or hinder their completion of the study.
  • Evidence of active acute or chronic hepatitis.
  • History of malignancy within 5 years before the screening visit or currently.
  • Pregnant or breastfeeding women, or women planning to become pregnant.
  • Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, 200050, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 31003, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

entacaponeAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 3
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

August 12, 2024

First Posted

August 15, 2024

Study Start

September 23, 2024

Primary Completion

October 12, 2025

Study Completion (Estimated)

August 16, 2026

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)