A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Dose Finding study to evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GSK1070806 SC injection in Adult Participants with Moderate to Severe Atopic Dermatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Glaxosmithkline Research & Development Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

10 Apr 2024 → 23 Jul 2025

Decision date (initial)

2024-03-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

GlaxoSmithKline Research & Development Limited

External identifiers

EU CT number

2023-505414-15-00

ClinicalTrials.gov

NCT05999799

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response

To evaluate the efficacy of GSK1070806 versus placebo in adults with moderate to severe AtD.

Conditions and MedDRA coding

Dermatitis, Atopic

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Participant and/or their LAR must sign and date an informed consent.
2. Adult participants 18 years to 75 years of age • Country specific requirement: Participants from South Korea are required to be aged at least 19 years or greater in the study. Participants from Thailand are required to be aged at least 20 years or greater in the study.
3. BMI within the range 18 - 39.9 kg/m2 (inclusive).
4. Disease Characteristics • AtD defined by the AAD Consensus Criteria [Eichenfield, 2014] (see Appendix 8). • Diagnosis of AtD ≥1 year • An IGA score ≥3 at both the Screening and Baseline visits • AtD involvement of ≥10% BSA at both the Screening and Baseline visits • EASI score ≥16 at both the Screening and Baseline visits • Baseline pruritus numerical rating scale average score for maximum intensity of at least 3, based on the average of daily pruritus numerical rating scale scores for maximum itch intensity reported during the 7 days prior to randomization.
5. AtD Medications: Biologic experienced participants: may have had exposure to 1 biologic therapy for atopic dermatitis such as, dupilumab, tralokinumab or lebrikizumab. Such participants must meet at least 1 of the following conditions: - Participants who stopped treatment due to non-response, partial response, loss of efficacy. - Participants who stopped treatment due to intolerance or AEs. Participants who have had prior exposure to a biologic therapy could have received it in either a marketed setting, or a research setting with documentation of the participants treatment allocation confirming prior exposure to active biologic therapy and not placebo OR • Biologic naive participants: who in addition to an inadequate response to optimization of non-pharmacological measures such as moisturizers, must meet at least 1 of the following conditions: • Participant with a recent history (≤6 months prior to the Screening visit) of inadequate response to a stable regimen of prescription topical medication • Participants for whom prescription topical medications are not tolerated • Participants where there is a concern for potential side effects, such as skin thinning or increased risk of hypothalamic-pituitary-adrenal suppression. Note: Inadequate response to a stable regimen of prescription topical medication (such as medium to high potency TCS or TCI) is defined as failure to achieve and maintain remission or low disease activity state (equivalent to an IGA score =0 [clear] to 2 [mild]) despite treatment for the recommended duration as per label or for the maximum duration recommended for the participant’s treatment, whichever is shorter.
6. Apply a stable dose of non-medicated topical moisturizer at least twice daily for ≥7 days prior to the baseline visit.
7. Completed electronic diary entries for PP-NRS for a minimum of 4 of 7 days preceding randomization.

Exclusion criteria 12

1. History of anaphylaxis as defined by the Sampson Criteria (Sampson, 2006)
2. History of significant allergies to monoclonal antibodies
3. Clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA, dermatosis, toxic epidermal necrolysis or Stevens-Johnson syndrome, and exfoliative dermatitis).
4. Other types of eczema such as allergic contact dermatitis
5. Any other concomitant skin disorder (e.g., generalized erythroderma such as Netherton’s Syndrome, or psoriasis), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AtD lesions or compromise participant safety.
6. Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, anti-protozoal, or antifungals within 4 weeks before the Screening visit or anytime between the Screening and Baseline visits.
7. Superficial skin infections within 1 week before the Screening visit or active infections (including localized infections), or history of recurrent infections (excluding recurrent fungal infections of the nail bed)
8. Known, pre-existing or suspected parasitic infection within 6 months before the Screening visit.
9. Symptomatic herpes zoster within 3 months prior to screening
10. Uncontrolled hypertension.
11. Medication or Treatment and Timeframe prior to baseline visit Use of medicated moisturizers (prescribed or over-the-counter) that are likely to impact participant’s AtD - 1 week Herbal or traditional treatments likely to impact participants AtD - 1 week TCS or TCI or topical JAKi - 1 week Systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, azathioprine, methotrexate, or any immunosuppressive therapy - 4 weeks Any biologic treatment for AtD, including but not limited to, dupilumab, tralokinumab, lebrikizumab or nemolizumab - 13 weeks for Dupilumab 15 weeks for Tralokinumab 18 weeks for Lebrikizumab 12 weeks for Nemolizumab For other biologics: 5 half-lives (if known) or 16 weeks, whichever is longer. Specific dermatological treatments include phototherapy, treatment with phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]) - 4 weeks Regular use (more than 2 visits per week) of a tanning booth/parlor - 4 weeks Any investigational drug - 8 weeks or within 5 half-lives (if known), whichever is longer Treatment with a live or live attenuated vaccine - 30 days of the baseline visit or planned to receive such vaccines during the study Any other biologic treatment including but not limited to TNF inhibitors (e.g., etanercept, adalimumab), IL inhibitors (e.g., tocilizumab, anakinra) or T-cell inhibitors (e.g., abatacept) Please note that inclusion of any prior biologic other than those mentioned in Inclusion Criteria #5 should be discussed with the Medical Monitor prior to enrollment - 5 half-lives (if known) or 16 weeks, whichever is longer B Cell-Depleting biologics, including rituximab - 6 months
12. Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma (defined by an ACQ-5 score ≥1.5 or a history of ≥ 2 asthma exacerbations within the last 12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalization for > 24 hours).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percent Change From Baseline in the Eczema Area and Severity Index (EASI) to Week 16.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Glaxosmithkline Research & Development Limited

Sponsor organisation

Glaxosmithkline Research & Development Limited

Address

G S K House, 980 Great West Road 980 Great West Road

City

Brentford

Postcode

TW8 9GS

Country

United Kingdom

Scientific contact point

Organisation

Glaxosmithkline Research & Development Limited

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

Glaxosmithkline Research & Development Limited

Contact name

EU GSK Clinical Trials Call Center

Third parties 25

Locations

8 EU/EEA countries · 41 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 263 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications