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Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis

S

Sunshine Guojian Pharmaceutical

Status and phase

Not yet enrolling
Phase 3

Conditions

Eczema, Atopic
Dermatitis, Atopic

Treatments

Drug: Topical corticosteroid
Drug: 611
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06554847
SSGJ-611-AD-III-02

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

400 participants in 3 patient groups, including a placebo group

611 interval 1+Topical Corticosteroid
Experimental group
Description:
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.
Treatment:
Drug: 611
Drug: Topical corticosteroid
611 interval 2+Topical Corticosteroid
Experimental group
Description:
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.
Treatment:
Drug: 611
Drug: Topical corticosteroid
Placebo+Topical Corticosteroid
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo
Drug: Topical corticosteroid

Trial contacts and locations

3

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Central trial contact

Qinghong Zhou

Data sourced from clinicaltrials.gov

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