Phase 1
N=29
A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT04316585 ↗Enrolled (actual)
29
Serious AEs
3.5%
Results posted
Mar 2024
Primary outcome: Primary: Percentage (%) of Participants Who Achieved Greater Than or Equal (>=) to 75% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12 — 5; 0 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- GSK2982772 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage (%) of Participants Who Achieved Greater Than or Equal (>=) to 75% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12 |
5; 0 | — |
| SECONDARY Percentage of Participants Who Achieved >=50% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12 |
42; 20 | — |
| SECONDARY Percentage of Participants Who Achieved >=90% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12 |
0; 0 | — |
| SECONDARY Percentage of Participants Who Achieved >=100% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12 |
0; 0 | — |
| SECONDARY Change From Baseline in Psoriasis Area Severity Index (PASI) Scores at Week 12 |
-8.82; -6.98 | — |
| SECONDARY Percentage of Participants Who Have a Static Investigator's Global Assessment (sIGA) Score of 0 or 1 at Week 12 |
11; 0 | — |
| SECONDARY Change From Baseline in Psoriatic Body Surface Area (BSA) at Week 12 |
-5.2; -3.7 | — |
| SECONDARY Number of Participants With Any Adverse Events (AEs) |
12; 6 | — |
| SECONDARY Number of Participants With Drug Related AEs |
5; 4 | — |
| SECONDARY Number of Participants With Common (Occurring at Least 5%) Non Serious AEs |
1; 0; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With AEs Leading to Permanent Discontinuation of Study Intervention |
2; 2 | — |
| SECONDARY Number of Participants With SAEs Including Any SAEs, SAEs Related to Study Intervention, and Fatal SAEs |
1; 0; 1; 0; 0; 0 | — |
Summary
Plaque psoriasis is a chronic relapsing inflammatory skin disease that is characterized by keratinocyte hyper-proliferation and epidermal hyperplasia. Standard treatment for psoriasis generally requires long-term use of topical therapies, psoralen and ultraviolet A (PUVA), ultraviolet B (UVB) and/or systemic immunosuppressant therapies to achieve and maintain adequate disease control. This is a multicenter, randomized, double-blind study conducted in participants with moderate to severe plaque psoriasis. The study will evaluate the efficacy, safety, pharmacokinetic and pharmacodynamics profile of 960 milligram (mg) GSK2982772 administered as a once daily modified release (MR) formulation. Participants will be randomized in a 2:1 ratio to receive either 960 mg GSK2982772 or placebo for 12 weeks. The duration of the study, including Screening and follow-up, will be approximately 21 weeks for each participant.
Eligibility Criteria
Inclusion Criteria
- Participants between 18 and 75 years of age inclusive, at the time of signing the informed consent.
- Diagnosis of plaque psoriasis for at least 6 months before Screening visit.
- Evidence of moderate to severe psoriasis, at Screening and Baseline before the first dose of study treatment, with: PASI score >=12; Psoriasis plaques involving BSA >=10 percent and sIGA>=3.
- Candidate for systemic therapy or phototherapy (includes naïve or previously treated), in the opinion of the Investigator.
- Agrees to avoid any prolonged exposure to natural or artificial sources of ultraviolet (UV) radiation from 28 days before Day 1 until the follow-up visit, which may potentially impact the participant's psoriasis in the opinion of the Investigator.
- Body mass index (BMI) within the range of 18.5 to 40.0 kilogram (kg)/meter square (m^2).
- Preclinical data has not identified risk of clinically relevant genotoxicity, however there is demonstrated/suspected risk of teratogenicity/fetotoxicity. Accordingly, the following contraceptive advice must be adhered to for male and female participants.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male participants are eligible to participate if they agree to the following during the intervention period and for at least 2 days (i.e. 5 terminal half-lives of GSK2982772) after the last dose of study intervention: Refrain from donating sperm plus either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed: Agree to use a male condom and will also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a WOCBP OR Is a WOCBP and using a contraceptive method that is highly effective preferably with low user dependency, during the intervention period and for at least 28 days (i.e. until resolution of potential drug interaction with combined hormonal contraceptives) after the last dose of study intervention. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (example an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.
Exclusion Criteria
- Non-plaque forms of psoriasis (example erythrodermic, guttate, or pustular), in the opinion of the Investigator.
- Drug-induced psoriasis (example a new onset of psoriasis or an exacerbation from beta blockers, calcium channel blockers, lithium or anti-Tumor-Necrosis Factor [TNF] therapies).
- Diagnosis of psoriatic arthritis, uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with psoriasis for which a participant requires current systemic (oral, subcutaneous [SC], or intravenous [IV]) (including corticosteroids and biologics) immu
Data sourced from ClinicalTrials.gov (NCT04316585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.