Clinical trial NCT05509023: Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2a Proof-of-Concept Study Evaluating the Safety and Efficacy of ADX-914 in Subjects With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Eczema Dermatitis
Lead sponsor: Q32 Bio Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-19
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase IIa, randomized, double-blind, placebo-controlled, multi-center proof-of-concept (POC) study in subjects with moderate to severe Atopic Dermatitis.

Detailed description: This is a two-part phase IIa, randomized, double-blind, placebo-controlled, multi-center proof-of-concept (POC) study in adult subjects with persistent moderate to severe Atopic Dermatitis (AD). ADX-914 or matching placebo for administered subcutaneously in the clinic setting every 2 weeks for 12 weeks, and follow-up for 12 weeks. ADX-914 or matching placebo will be in the clinic setting post-randomization. In Part A, up to 3 cohorts of subjects will be randomized 2:1 drug vs placebo. In Part B subjects will be randomized 1:1 to drug vs placebo at a doses selected in Part A.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years, inclusive, at time of informed consent, with chronic AD (duration of disease ≥3 years) diagnosed by the Eichenfield revised criteria of Hanifin and Rajka.
2. Moderate to severe disease activity at baseline and screening defined as:

   1. BSA affected ≥10%
   2. EASI Score ≥12
   3. Investigators Global Score (IGA) ≥3
3. Who, in the opinion of the Investigator, have a history of inadequate response to at least one of the following:

   1. at least 4-week course of medium-potency topical steroids or other approved topical immunomodulators (calcineurin, PDE-4 and JAK inhibitors)
   2. systemic steroids or phototherapy
   3. oral chemical synthetic immunomodulators (MTX, mycophenolate mofetil, azathioprine, cyclosporine, systemic approved biologics \[dupliumab, ustekinumab or tralokinumab\]), or approved systemic targeted synthetic JAK inhibitors (upadacitinib, abrocitinib)

Exclusion Criteria:

1. Body weight ≤ 50.0 kg for men and ≤ 45.0 kg for women and \> 120 kg at Screening
2. Rescue therapy, topical or systemic, need anticipated within 4 weeks of randomization
3. Recent (within 2 months of informed consent) or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection
4. A positive QuantiFERON®TB Gold test at Screening or history of tuberculosis (TB)
5. Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to receive a live vaccine during the study
6. Systemic, topical or device-based therapy of AD
7. Serious concomitant illness that could require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring
8. Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on atopic dermatitis
9. Other active autoimmune diseases other than those above that would make it difficult to appropriately assess AD disease activity or pose a risk to the subject's participation in the trial
10. Pregnant or lactating women, or women planning to become pregnant or initiate breastfeeding.
11. History of sensitivity to any of the study treatments, or components thereof, or a history of drug or other allergy that, in the opinion of the Investigator, contraindicates their participation.
12. Has been in another investigational trial within 30 days or 5 half-lives of the investigational agent (whichever is greater) prior to the informed consent.

Primary outcomes:
measure: Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest
timeFrame: 14 Weeks
measure: Part A and B: Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 for ADX-914 vs placebo
timeFrame: 14 Weeks
Secondary outcomes:
measure: Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score
timeFrame: 24 Weeks
measure: Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score
timeFrame: 24 Weeks
measure: Proportion of subjects achieving Eczema Area and Severity Index (EASI) reduction of 50%, 75% and 90%
timeFrame: 24 Weeks
measure: Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with at least 2 grades of reduction from Baseline
timeFrame: 24 Weeks
measure: Incidence of adverse events
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology Skin Health Center
state: Alabama
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group- Los Angeles
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: Santa Monica
country: United States
facility: Dermatology Institute and Skin Care Center
state: California
city: Torrance
country: United States
facility: Torrance Clinical Research Institute Inc.
state: California
city: Upland
country: United States
facility: Integrated Research of Inland, Inc.
state: California
city: Homestead
country: United States
facility: RM Medical Research Inc.
state: Florida
city: Miami
country: United States
facility: Medical Research Center of Miami
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corporation
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research, PC
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Normal
country: United States
facility: Sneeze wheeze and Itch Associates LLC
state: Illinois
city: New Albany
country: United States
facility: Southern Indiana Clinical Trials
state: Indiana
city: Largo
country: United States
facility: Visage Clinical Research
state: Maryland
city: Troy
country: United States
facility: Revival Research Corporation- Clinedge
state: Michigan
city: Painesville
country: United States
facility: Apex Clinical Research Center
state: Ohio
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Frisco
country: United States
facility: North Texas Center for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
city: Seattle
country: United States
facility: Dermatology of Seattle & Bellevue
state: Washington
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
Study officials:
References: