Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.

NCT06447506 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2207232023-508474-29-00
• Study Type: interventional
• Target: 79
• Locations: 15 countries
• Sites: 51

Brief Summary

The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).

Conditions

Dermatitis, Atopic

Keywords

Atopic dermatits; Dermatitis; Eczema; GSK1070806; Safety; Efficacy; Immune system Disease

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state. Safety Analysis Set included all assigned participants who received at least 1 dose of study intervention in this LTE study. Participants were analyzed according to the intervention they actually received.

  Up to Week 59

• Number of Participants With TEAEs Leading to Permanent Discontinuation

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state. Number of participants with TEAE leading to permanent discontinuation of GSK1070806 were reported.

  Up to Week 59

• Number of Participants With Serious Adverse Events (SAEs)

  An SAE is defined as any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), is a suspected transmission of any infectious agent via an authorized medicinal product, and medically important were categorized as SAE.

  Up to Week 59

• Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESI)

  AESI for GSK1070806 include serious infections, opportunistic infections, serious hypersensitivity reactions, and injection site reactions (ISRs). A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state.

  Up to Week 59

Secondary Outcomes (6)

• Number of Participants Who Achieved Investigators Global Assessment (IGA) Response (IGA Score of 0 or 1 and a Reduction of Greater Than or Equal to [>=]2 Points From Baseline) at Weeks 16, 32, and 48

  Baseline (Day 1 from the parent study), Weeks 16, 32, and 48

• Number of Participants Who Achieved Reduction of Greater Than or Equal to (>=) 75 Percent (%) in Eczema Area and Severity Index (EASI) Score From Baseline at Weeks 16, 32 and 48

  Baseline (Day 1 from the parent study), Weeks 16, 32 and 48

• Number of Participants Who Achieved Reduction of >=4 Points in Peak Pruritus Numerical Rating Scale (PP-NRS) Score From Baseline at Weeks 16, 32, and 48

  Baseline (Day -7 to Day -1 from the parent study), Weeks 16, 32, and 48

• Number of Participants Who Maintained IGA Response (IGA Score of 0 or 1 and a Reduction of >=2 Points From Baseline) at Weeks 16, 32, and 48

  Baseline (Day 1 from the parent study), Weeks 16, 32, and 48

• Number of Participants Who Maintained Response of Reduction of >= 75% in EASI Score From Baseline at Weeks 16, 32, and 48

  Baseline (Day 1 from the parent study), Weeks 16, 32, and 48

Study Arms (9)

Placebo/Placebo

PLACEBO COMPARATOR

Participants were previously treated with placebo in parent Study 219538 (NCT05999799) and continued on placebo subcutaneous (SC) injection in this long-term extension (LTE) study.

Drug: Placebo

Placebo/GSK1070806 Dose Level 4

EXPERIMENTAL

Participants were previously treated with placebo in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.

Drug: GSK1070806; Drug: Placebo

GSK1070806 Dose Level 1/GSK1070806 Dose Level 1

EXPERIMENTAL

Participants were previously treated with GSK1070806 dose level 1 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 1 SC injection in this LTE study. Dose level 1 is the lowest dose level.

Drug: GSK1070806

GSK1070806 Dose Level 1/GSK1070806 Dose Level 4

EXPERIMENTAL

Participants were previously treated with GSK1070806 dose level 1 in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.

Drug: GSK1070806

GSK1070806 Dose Level 2/GSK1070806 Dose Level 2

EXPERIMENTAL

Participants were previously treated with GSK1070806 dose level 2 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 2 SC injection in this LTE study. Dose level 2 is greater than dose level 1.

Drug: GSK1070806

GSK1070806 Dose Level 2/GSK1070806 Dose Level 4

EXPERIMENTAL

Participants were previously treated with GSK1070806 dose level 2 in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.

Drug: GSK1070806

GSK1070806 Dose Level 3/GSK1070806 Dose Level 3

EXPERIMENTAL

Participants were previously treated with GSK1070806 dose level 3 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 3 SC injection in this LTE study. Dose level 3 is greater than dose level 2.

Drug: GSK1070806

GSK1070806 Dose Level 3/GSK1070806 Dose Level 4

EXPERIMENTAL

Participants were previously treated with GSK1070806 dose level 3 in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.

Drug: GSK1070806

GSK1070806 Dose Level 4/GSK1070806 Dose Level 4

EXPERIMENTAL

Participants were previously treated with GSK1070806 dose level 4 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.

Drug: GSK1070806

Interventions

GSK1070806 DRUG

Participants will receive GSK1070806

GSK1070806 Dose Level 1/GSK1070806 Dose Level 1; GSK1070806 Dose Level 1/GSK1070806 Dose Level 4; GSK1070806 Dose Level 2/GSK1070806 Dose Level 2; GSK1070806 Dose Level 2/GSK1070806 Dose Level 4; GSK1070806 Dose Level 3/GSK1070806 Dose Level 3; GSK1070806 Dose Level 3/GSK1070806 Dose Level 4; GSK1070806 Dose Level 4/GSK1070806 Dose Level 4; Placebo/GSK1070806 Dose Level 4

Placebo DRUG

Participants will receive Placebo

Placebo/GSK1070806 Dose Level 4; Placebo/Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must sign and date the consent document.
• Participants diagnosed with moderate to severe Atopic dermatitis (AtD) who have completed the qualifying Phase 2 parent study (NCT05999799) of GlaxoSmithKline (GSK's) AtD and, in their opinion, may benefit from GSK1070806.
• Be intentional and able to visit the doctor at the clinic by appointment and follow all procedures related to research studies and questionnaires (able to read and understand Patient-reported outcomes (PRO) questionnaires and be able to use electronic devices).
• The use of contraceptive methods for females should be consistent with local regulations on contraceptive methods of participants participating in clinical research programs.
• Female participants are eligible to participate in the research program if they are not pregnant or breastfeeding and meet one of the following conditions:
• It is Woman of nonchildbearing potential (WONCBP).
• It is Woman of childbearing potential (WOCBP) and uses a highly effective contraceptive method that has a failure rate less than (\<) 1 percent (%) during the trial dose period and for at least 16 weeks after the last dose of the research drug. We should assess the likelihood of contraceptive failure (e.g., non-cooperation, early contraception) associated with the first dose of the drug.
• WOCBP must obtain a negative result in a highly sensitive pregnancy test (by urine or serum test, as prescribed by local regulations) before receiving the first dose of the research drug.
• If the urine test is positive, or the negative result cannot be confirmed (i.e., the result is unclear), a pregnancy test by serum test is required. In such cases, If the serum is tested, the test result is positive. Participants must be excluded from the research project.
• Additional requirements for testing pregnancy during and after exposure to the drug.
• The researcher is responsible for examining medical history, menstrual cycle history, and sexual activity in the near term. To reduce the risk of screening pregnant women who may not be detected at the beginning of pregnancy.

You may not qualify if:

• Permanent discontinuation of the study drug at any time during GSK's qualifying Phase 2 AtD (NCT05999799) or a medical condition that would hinder GSK's participation in the Phase 2 219538 (NCT05999799) AtD research project.
• Participants who, during GSK's qualifying Phase 2 (NCT05999799) AtD research project, developed adverse event (AE) or Serious adverse event (SAE) based on laboratory parameters, physical examination, vital signs, Electrocardiogram (ECG), medical history, etc. Medical history, in the opinion of the researchers, suggests that if Investigational medicinal product (IMP) is continued, it may cause unnecessary risk to the participants.
• Topical medications for AtD within 1 week prior to your appointment at Day 1, such as: Topical calcineurin inhibitors (TCI)/ Topical corticosteroids (TCS), Phosphodiesterase-4 (PDE-4) and Janus activation kinase inhibitors (JAKi) for external use.
• Topical corticosteroids (TCS) (such as hydrocortisone, betamethasone)
• Topical calcineurin inhibitors (TCI) (such as tacrolimus, pimecrolimus)
• Phosphodiesterase-4 (PDE4) inhibitor for external use (e.g., crisaborole)
• JAKi for external use (e.g. ruxolitinib)
• Medications for topical use, or other herbal/traditional medicines that may affect the AtD that the participants are in.
• Participant who received systemic therapy, which is considered contraindicated, including systemic therapy used as a rescue medication for AtD, from the screening for GSK's Phase 2 AtD 219538 research project until the LTE protocol began, were unable to participate in the research project.
• Chronic uncontrolled diseases that may require immediate oral corticosteroids, such as severe uncontrolled asthma (defined as having an Asthma control questionnaire (ACQ)-5 score greater than or equal to (\>=) of 1.5 or a history of asthma exacerbations. \>= 2 times within the last 12 months, requiring systemic corticosteroid \[oral and/or intravenous medication\] or requiring a \>-24-hour hospital stay)
• Experience participating in previous/current clinical research projects.
• The participants have participated in any other clinical research studies. This is in addition to GSK's Phase 2 219538 (NCT05999799) research project.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (51)

GSK Investigational Site

Fountain Valley, California, 92708, United States

Location

GSK Investigational Site

Pompano Beach, Florida, 33334, United States

Location

GSK Investigational Site

Fayetteville, Georgia, 30214, United States

Location

GSK Investigational Site

New York, New York, 10075, United States

Location

GSK Investigational Site

Dublin, Ohio, 43016, United States

Location

GSK Investigational Site

Santa Monica, Texas, 90404, United States

Location

GSK Investigational Site

Buenos Aires, C1055AAO, Argentina

Location

GSK Investigational Site

Buenos Aires, C1181ACH, Argentina

Location

GSK Investigational Site

Ciudad Autonoma de Bueno, C1056ABI, Argentina

Location

GSK Investigational Site

Córdoba, X5000AAW, Argentina

Location

GSK Investigational Site

Rosario, S2002, Argentina

Location

GSK Investigational Site

Pleven, 5800, Bulgaria

Location

GSK Investigational Site

Sofia, 1510, Bulgaria

Location

GSK Investigational Site

Barrie, Ontario, L4M 7G1, Canada

Location

GSK Investigational Site

London, Ontario, N6H 5L5, Canada

Location

GSK Investigational Site

Markham, Ontario, L3P1X2, Canada

Location

GSK Investigational Site

Chongqing, 400016, China

Location

GSK Investigational Site

Hangzhou, 310000, China

Location

GSK Investigational Site

Shanghai, 200025, China

Location

GSK Investigational Site

Shanghai, China

Location

GSK Investigational Site

Prague, 10034, Czechia

Location

GSK Investigational Site

Prague, Czechia

Location

GSK Investigational Site

La Rochelle, 17019, France

Location

GSK Investigational Site

Berlin, 10789, Germany

Location

GSK Investigational Site

Münster, 48149, Germany

Location

GSK Investigational Site

Athens, Greece

Location

GSK Investigational Site

Chiba, 272-0033, Japan

Location

GSK Investigational Site

Fukuoka, 807-8556, Japan

Location

GSK Investigational Site

Fukuoka, 812-8582, Japan

Location

GSK Investigational Site

Gunma, 370-0829, Japan

Location

GSK Investigational Site

Hokkaido, 060-0033, Japan

Location

GSK Investigational Site

Hokkaido, 080-0013, Japan

Location

GSK Investigational Site

Kanagawa, 211-0063, Japan

Location

GSK Investigational Site

Osaka, 583-8588, Japan

Location

GSK Investigational Site

Osaka, 593-8324, Japan

Location

GSK Investigational Site

Saitama, 343-8555, Japan

Location

GSK Investigational Site

Chihuahua City, 31000, Mexico

Location

GSK Investigational Site

Durango, 34000, Mexico

Location

GSK Investigational Site

Guadalajara, 44628, Mexico

Location

GSK Investigational Site

Panama City, 7099, Panama

Location

GSK Investigational Site

Elblag, 82-300, Poland

Location

GSK Investigational Site

Katowice, 40-600, Poland

Location

GSK Investigational Site

Szczecin, 70-332, Poland

Location

GSK Investigational Site

Ansan, 15355, South Korea

Location

GSK Investigational Site

Seoul, 03722, South Korea

Location

GSK Investigational Site

Seoul, 04763, South Korea

Location

GSK Investigational Site

Seoul, 100 799, South Korea

Location

GSK Investigational Site

Seoul, 150-950, South Korea

Location

GSK Investigational Site

Córdoba, 14004, Spain

Location

GSK Investigational Site

Granada, 18016, Spain

Location

GSK Investigational Site

Vigo, 36206, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Eczema; Immune System Diseases

Interventions

GSK1070806

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity

Limitations and Caveats

This study was terminated after the parent study 219538 (NCT05999799) met pre-defined futility criteria.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double blinded study until the qualifying parent study has reported out.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: June 5, 2024
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: June 16, 2026
• Results First Posted: June 16, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

FR (1); PL (3); KR (5); ES (3); AR (5); GR (1); JP (10); US (6); BU (2); PA (1); CZ (2); DE (2); CN (4); ME (3); CA (3)