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PsoriasisPhase 3NCT03202004

GSK2894512 Vehicle-Controlled Study for Adult Plaque Psoriasis

A Phase 3 study testing GSK2894512 1% cream in people with Psoriasis, run by GlaxoSmithKline.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will evaluate the efficacy and safety of GSK2894512 cream for the topical treatment of plaque psoriasis (psoriasis) with its vehicle cream. This is a randomized, double-blind, vehicle-controlled, parallel-group, multicenter study in adults with psoriasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
GSK2894512 1% cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
22 Jan 2018to 28 Sep 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >=18 years at the time of signing the informed consent.
  • Clinical diagnosis of chronic stable plaque psoriasis. Diagnosis and chronicity to be confirmed and documented by an experienced dermatologist.
  • Body surface area involvement >=2%.
  • A PGA score of >=2.
  • One target plaque located on the trunk or extremities that is at least 9 centimeter (cm)^2 in size with a target plaque severity score (TPSS) >=5 and an induration sub score >=2. Primary target plaque should not be located on the knees, elbows, feet, ankle, hands, intertriginous areas, face, or scalp.)
  • Male or female. A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
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  • Not a woman of childbearing potential (WOCBP), OR
  • Is a WOCBP who agrees to follow the specified contraceptive guidance throughout the study, including screening, during the treatment period, and for at least 1 week after the last exposure to study treatment.
  • Capable of giving signed informed consent

Who cannot join

  • Psoriasis other than plaque variant.
  • Any sign of infection of any of the psoriatic lesions.
  • Concurrent conditions and history of other diseases:
  • Immunocompromised (examples: lymphoma, acquired immunodeficiency syndrome) or have a history of malignant disease within 5 years before the Baseline visit.
  • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the Baseline visit.
  • Active acute bacterial, fungal, or viral (examples: herpes simplex, herpes zoster, chicken pox) skin infection within 1 week before the Baseline visit
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  • Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the investigator's opinion, would make it difficult to interpret data or assessments during the study.
  • A history or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, may interfere with the subject's completion of the study.
  • Known hypersensitivity to GSK2894512 or excipients of the study treatments, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation.
  • Alanine transferase (ALT) >2 times upper limit of normal (ULN).
  • Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
  • Stable chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C, examples: presence of hepatitis B surface antigen [HBsAg] or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment) is acceptable if the subject otherwise meets entry criteria.
  • QT interval corrected for heart rate according to Fridericia's formula QTcF >450 milliseconds (msec) or QTcF >480 msec in subjects with bundle branch block.
  • Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation (examples: phototherapy, tanning beds/booths, or therapeutic sunbathing) within 4 weeks prior to the Baseline visit and/or intention to have such exposure during the study, which could potentially impact the subject's psoriasis (as determined by the investigator).
  • Used any of the following treatments within the indicated period before the Baseline visit:
  • Minimum of 5 half-lives for biologic agents -12 months: rituximab or efalizumab; 8 months: ustekinumab; 5 months: secukinumab; 12 weeks: golimumab; 10 weeks: ixekizumab; 8 weeks: infliximab, adalimumab, or alefacept; 4 weeks: etanercept (list is not exclusive, contact medical monitor for questions).
  • 4 weeks -systemic treatments: cyclosporin, interferon, methotrexate, apremilast, tofacitinib, mycophenolate, thioguanine, hydroxyurea, sirolimus, azathioprine, other systemic immunosuppressive or immunomodulating agents, fumaric acid derivatives, vitamin D3 and analogs, retinoids (examples: acitretin, isotretinoin), psoralens, corticosteroids, or adrenocorticotropic hormone analogs.
  • 2 weeks -immunizations; drugs known to possibly worsen psoriasis, such as beta-blockers (example, propranolol), lithium, iodides, angiotensin-converting enzyme inhibitors, and indomethacin, unless on a stable dose for >12 weeks.
  • 2 weeks -topical treatments: corticosteroids, immunomodulators, anthralin (dithranol), Vitamin D derivatives (examples: calcipotriene, calcipotriol), retinoids (example, tazarotene), or coal tar (used on the body).
  • Participated in a clinical study and received an investigational product within the following time period prior to the Baseline visit: 4 weeks, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Participated in a previous study using GSK2894512 or WBI-1001.

About this study

Official title: A Double-Blind Safety and Efficacy Study of GSK2894512 Cream Versus Vehicle in the Treatment of Adult Plaque Psoriasis

This study will evaluate the efficacy and safety of GSK2894512 cream for the topical treatment of plaque psoriasis (psoriasis) with its vehicle cream. This is a randomized, double-blind, vehicle-controlled, parallel-group, multicenter study in adults with psoriasis. The aim of this study is to show superiority of GSK2894512 over vehicle by comparing their response rates. The study will consist of 3 periods: up to 4 weeks screening, 12 weeks blinded treatment, and 1 week post-treatment follow-up period. Subjects will apply randomized study treatment to all psoriasis lesions once daily for 12 weeks. Subjects will be stratified by Baseline physician global assessment (PGA) category (PGA score=2, PGA score >=3) at randomization. Approximately 120 subjects will be randomized into the study of which 80 will receive GSK2894512 1% cream and 40 will receive vehicle cream. Total duration of a subject's participation in the study will be approximately for 14 to 17 weeks.

Conditions
Psoriasis
Being tested
GSK2894512 1% cream, Vehicle cream
Keywords
PGA, efficacy, PASI, GSK2894512, NRS, Topical, psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK2894512 1% creamDrug

    1 % (10 mg/g) GSK2894512 cream will be provided in tubes labeled in compliance with country requirements.

  • Vehicle creamDrug

    Vehicle cream will be provided in tubes labeled in compliance with country requirements.

Study groups in NCT03202004
Study groupRoleWhat they receive
GSK2894512 1% cream groupExperimentalSubjects will apply a thin layer of GSK2894512 1% (10 milligrams per gram [mg/g]) topical cream once daily to all psoriasis lesions for 12 weeks. The study staff will instruct subjects on proper topical application of cream.
Receives: Drug: GSK2894512 1% cream
Vehicle cream groupPlacebo comparatorSubjects will apply a thin layer of vehicle cream once daily to all psoriasis lesions for 12 weeks. The study staff will instruct subjects on proper topical application of cream.
Receives: Drug: Vehicle cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion OF SUBJECTS WITH PGA SCORE OF CLEAR OR ALMOST CLEAR (0 OR 1) AND A MINIMUM 2-GRADE IMPROVEMENT IN PGA SCORE FROM BASELINE AND WEEK 12

    PGA is a clinical tool (a 5 point scale) for assessing the current state/severity of a subject's psoriasis. It is a morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Subjects will be scored using the following categories: 0=Clear; 1=Almost clear; 2=Mild; 3=Moderate; and 4=Severe.

    Measured: Baseline (Day 1) and Week 12

Secondary outcomes (2)

  1. Proportion of subjects with >=75% improvement in Psoriasis Area and Severity Index (PASI) from Baseline to Week 12

    The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of percent body surface area (%BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=None; 4=Severe) and the % BSA affected is scored on a 7-point scale (0=0%; 6>=90%) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease.

    Measured: Baseline (Day 1) and up to Week 12

  2. Proportion OF SUBJECTS WITH>=3-POINT REDUCTION IN WEEKLY AVERAGE ITCH/PRURITUS NUMERIC RATING SCALE (NRS) FROM BASELINE TO WEEK 12 FOR SUBJECTS WITH A BASELINE SCORE >=4

    The severity and bother of psoriasis-related itching, stinging, burning, pain, and scaling and impact items about the embarrassment, avoidance of activities with other people, and movement restrictions will be assessed using Psoriasis Symptom Diary. It is a 16-item electronic, daily (24-hour recall), validated assessment that measures self-reports of psoriasis symptoms and impact on functional health. Each item will be rated on a 0 to 10 NRS, with unlabeled numbers in between the labeled anchors. Higher scores indicate more severe symptoms, bother, or impact.

    Measured: Baseline (Day 1) and up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2017
  2. Study start22 Jan 2018 (estimated)
  3. Primary completion28 Sep 2018 (estimated)
  4. Study completion28 Sep 2018 (estimated)

Why it stopped: The decision not to progress the planned Phase 3 studies is a business decision based on the need to prioritise and focus resources within GSK.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03202004
Sponsor's protocol ID
200852
Status last verified
Dec 2017
First submitted
27 Jun 2017
Last updated
7 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK2894512 1% cream in people with Psoriasis, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion OF SUBJECTS WITH PGA SCORE OF CLEAR OR ALMOST CLEAR (0 OR 1) AND A MINIMUM 2-GRADE IMPROVEMENT IN PGA SCORE FROM BASELINE AND WEEK 12 (time frame: Baseline (Day 1) and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03202004.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.

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