PsoriasisPhase 1NCT02548052
Study of Safety and Efficacy of Topical GSK2981278 Ointment in Plaque Psoriasis
A Phase 1 study testing GSK2981278 0.03%, GSK2981278 0.1% and GSK2981278 0.8% in people with Psoriasis, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
GSK2981278 is a highly potent and selective inverse agonist of retinoic acid receptor-related orphan receptor gamma (ROR gamma) that is under development for topical treatment of plaque type psoriasis suitable for topical therapy. This is the first study to administer GSK2981278 to subjects 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?
- GSK2981278 0.03%, GSK2981278 0.1% and GSK2981278 0.8%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 22 Oct 2015to 19 Feb 2016
- Phase
- Phase 1
- 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
- 18 years of age and above, at the time of signing the informed consent.
- Subjects with stable plaque psoriasis for >= 6 months, as confirmed by the subject.
- Up to three plaque area(s) sufficient for six test fields. The target lesion(s) should be on the trunk, upper extremities or thighs (excluding hands and skin folds); psoriatic lesion(s) on the knees or elbows are not to be used as a target lesion. It is recommended, but not required, that all selected plaques are symmetrical in location, size and clinical characteristics.
- Plaques to be treated should have a comparable thickness of the Echo Lucent Band (ELB) (as a surrogate for the psoriatic infiltrate thickness) of at least 200 micrometers on Day 1.
- Male:
- Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until after the last dose of study medication.
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- Vasectomy with documentation of azoospermia.
- Male condom. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
- Female of non-reproductive potential (FNRP):
- A FNRP is eligible to participate in this study if she meets at least one of the following conditions:
- Females with one of the following procedures documented and no plans to utilize assisted reproductive techniques (e.g., in vitro fertilization or donor embryo transfer): Bilateral tubal ligation or salpingectomy; Hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Bilateral Oophorectomy (surgical menopause)
- Post-menopausal women (including all women over 60 years of age, see below), Post-Menopause criteria: Females 60 years of age or older; A practical definition accepts menopause after 1 year without menses with an appropriate clinical profile, e.g., age appropriate, >45 years, in the absence of hormone replacement therapy (HRT) or medical suppression of the menstrual cycle (e.g., leuprolide treatment) [In questionable cases for women < 60 years of age, a blood sample with simultaneous follicle stimulating hormone and estradiol falling into the central laboratory's post-menopausal reference range is confirmatory (these levels need to be adjusted for specific laboratories/assays)]; Females under 60 years of age, who are on HRT and wish to continue, and whose menopausal status is in doubt, are required to use a highly effective method to avoid pregnancy, as outlined in the protocol. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a highly effective method to avoid pregnancy
- Capable of giving signed informed consent, which includes compliance with the pre-specified requirements and restrictions.
Who cannot join
- Alanine aminotransferase (ALT) >2xUpper Limit of Normal (ULN) and bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Corrected QT (QTc) interval > 450 milliseconds (msec) or QTc > 480 msec in subjects with Bundle Branch Block. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), and/or machine-read. The QTc should be based on single QTc values of ECG obtained over a brief recording period.
- Any condition that, in the judgement of the investigator, would put the subject at unacceptable risk for the participation in the trial.
- Current evidence of another ongoing or any acute cutaneous infection, history of repeated or chronic significant skin infections (unless irrelevant in the opinion of the investigator, i.e. onychomycosis, labial herpes or other minor diagnosis).
- Clinically-relevant skin disease, other skin pathologies, or a history of skin cancer, that may, in the opinion of the investigator, contraindicate participation or interfere with test field evaluations.
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- History of malignancy within 5 years prior to dosing, except adequately treated noninvasive cancer of the skin (basal or squamous cell).
- Psoriasis other than plaque variants.
- Use of prohibited concomitant medications or products within the defined washout periods before the Day 1 visit and during the trial.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
- Contraindications according to summary of product characteristics of the active positive control.
- Symptoms of a clinically significant illness that may, in the opinion of the investigator, influence the outcome of the trial in the 4 weeks before baseline visit and during the trial.
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Prolonged exposure to natural or artificial sources of ultraviolet (UV) radiation within 2 weeks prior to the Day 1 visit or intention to have such exposure during the study, thought by the investigator likely to modify the subject's psoriasis.
- In the opinion of the investigator or physician performing the initial examination the subject should not participate in the clinical trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent.
- Close affiliation with the investigator (e.g. a close relative) or persons working at Bioskin GmbH or subject is an employee of sponsor.
- Subject is institutionalized because of legal or regulatory order.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Trial to Evaluate Safety and Efficacy of Topically Applied GSK2981278 Ointment in a Psoriasis Plaque Test
GSK2981278 is a highly potent and selective inverse agonist of retinoic acid receptor-related orphan receptor gamma (ROR gamma) that is under development for topical treatment of plaque type psoriasis suitable for topical therapy.
This is the first study to administer GSK2981278 to subjects with psoriasis. This proof-of-concept study will evaluate the safety, tolerability and initial efficacy of a range of concentrations of GSK2981278 ointment with repeated topical applications in adult subjects with psoriasis. Results of this study will provide first clinical information on the drug's safety and efficacy in psoriasis and inform the selection of concentration of GSK2981278 ointment to be evaluated in subsequent clinical studies.
Read more
This is a Phase 1, single center, test field-randomized, vehicle- and positive- controlled, subject- and evaluator-blind study. All subjects will receive all 6 treatments on 6 test fields, for intra-individual treatment comparison. For every subject, the manner of assignment of each treatment to a particular test field will be according to a randomization scheme. Thus, the test fields within each subject, and not the subjects themselves, will be randomized.
The study will consist of screening, followed by a treatment period of 19 days, and a follow-up visit at Day 27 (+/-2) for subjects who will consent for biopsy. During the treatment period, subjects will receive all of these treatments: GSK2981278 ointment 0.03% weight by weight [w/w], 0.1% w/w, 0.8% w/w, 4% w/w, GSK2981278 vehicle, and betamethasone valerate 0.1% cream. The test fields on which these treatments will be applied will be identified on stable plaque(s) on the upper extremities, thighs and/or trunk. A blinded evaluator (an investigator or designee) will perform the measurements and assessments whereas an unblinded study staff member (not an evaluator) will perform biopsy collection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2981278 0.03%Drug
GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.03%. Approximately 200 microliters of the GSK2981278 0.03% ointment will be applied topically to the assigned test field once daily.
GSK2981278 0.1%Drug
GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.1%. Approximately 200 microliters of the GSK2981278 0.1% ointment will be applied topically to the assigned test field once daily.
GSK2981278 0.8%Drug
GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.8%. Approximately 200 microliters of the GSK2981278 0.8% ointment will be applied topically to the assigned test field once daily.
GSK2981278 4%Drug
GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 4%. Approximately 200 microliters of the 4% ointment will be applied topically to the assigned test field once daily.
VehicleDrug
GSK2981278 vehicle will be supplied as a white to off-white ointment containing no drug substance. Approximately 200 microliters of the vehicle will be applied topically to the assigned test field once daily.
Betamethasone valerate 0.1%Drug
Betamethasone valerate will be supplied as a cream. Approximately 200 microliters of the 0.1% betamethasone valerate cream will be applied topically to the assigned test field once daily.
| Study group | Role | What they receive |
|---|---|---|
| GSK2981278, Vehicle, Betamethasone valerate | Experimental | All subjects will receive all six treatments (GSK2981278 ointment 0.03%, 0.1%, 0.8%, 4%, vehicle to match GSK2981278 ointment and betamethasone valerate 0.1% cream); with random assignment of the treatments to 6 test fields on identified stable plaque(s) on the upper extremities, thighs and/or trunk. Subjects will be treated once-daily (except Days 7 and 14) over 19 days (a total of 16 applications) under semi-occlusive conditions (covered by an adhesive non-woven fabric). Receives: Drug: GSK2981278 0.03%; Drug: GSK2981278 0.1%; Drug: GSK2981278 0.8%; Drug: GSK2981278 4%; Drug: Vehicle; Drug: Betamethasone valerate 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: From Day 1 until follow-up visit (Day 27)
Change from baseline in clinical laboratory parameters
Measured: Baseline and Days 8, 15, and 19
Change from baseline in heart rate
Measured: Baseline and Day 19
Change from baseline in systolic and diastolic blood pressure
Measured: Baseline and Day 19
Change from baseline in oral temperature
Measured: Baseline and Day 19
Change from baseline in electrocardiogram (ECG)
Single 12-lead ECGs will be obtained using an ECG machine that automatically calculates heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals.
Measured: Baseline and Days 15 and 19
Reduction in infiltrate thickness of the psoriatic plaque(s) from baseline
Infiltrate thickness will be measured by 22-MegaHertz high-frequency sonography. Sonography will be done on Days 1, 4, 8, 15, and 19.
Measured: Baseline (Day 1) and Days 4, 8, 15, and 19
Secondary outcomes (1)
Clinical assessment score using a 5- point scale
Improvement of the test site(s) will be assessed using a 5-point scale with score ranging from -1 (worsened) to 3 (completely healed). Score at Day 1 will be documented as "zero".
Measured: Baseline (Day 1) and Days 4, 8, 15, and 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study start22 Oct 2015
- Primary completion19 Feb 2016
- Study completion19 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548052
- Sponsor's protocol ID
- 201465
- Status last verified
- May 2017
- First submitted
- 10 Sep 2015
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kang EG, Wu S, Gupta A, von Mackensen YL, Siemetzki H, Freudenberg JM, Wigger-Alberti W, Yamaguchi Y. A phase I randomized controlled trial to evaluate safety and clinical effect of topically applied GSK2981278 ointment in a psoriasis plaque test. Br J Dermatol. 2018 Jun;178(6):1427-1429. doi: 10.1111/bjd.16131. Epub 2018 Mar 23. No abstract available.
PubMed 29150844
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial to Evaluate Safety and Efficacy of Topically Applied GSK2981278 Ointment in a Psoriasis Plaque Test
- ClinicalTrials.gov ID
- NCT02548052
- Acronym / sponsor ID
- 201465
- Conditions
- Psoriasis
- Keywords
- retinoic acid receptor-related orphan receptor (ROR) gamma inverse agonist, Plaque type psoriasis, psoriasis plaque test, Topical, GSK2981278
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2015 (actual)
- Primary completion
- 19 Feb 2016 (actual)
- Study completion
- 19 Feb 2016 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GSK2981278 is a highly potent and selective inverse agonist of retinoic acid receptor-related orphan receptor gamma (ROR gamma) that is under development for topical treatment of plaque type psoriasis suitable for topical therapy.
This is the first study to administer GSK2981278 to subjects with psoriasis. This proof-of-concept study will evaluate the safety, tolerability and initial efficacy of a range of concentrations of GSK2981278 ointment with repeated topical applications in adult subjects with psoriasis. Results of this study will provide first clinical information on the drug's safety and efficacy in psoriasis and inform the selection of concentration of GSK2981278 ointment to be evaluated in subsequent clinical studies.
This is a Phase 1, single center, test field-randomized, vehicle- and positive- controlled, subject- and evaluator-blind study. All subjects will receive all 6 treatments on 6 test fields, for intra-individual treatment comparison. For every subject, the manner of assignment of each treatment to a particular test field will be according to a randomization scheme. Thus, the test fields within each subject, and not the subjects themselves, will be randomized.
The study will consist of screening, followed by a treatment period of 19 days, and a follow-up visit at Day 27 (+/-2) for subjects who will consent for biopsy. During the treatment period, subjects will receive all of these treatments: GSK2981278 ointment 0.03% weight by weight [w/w], 0.1% w/w, 0.8% w/w, 4% w/w, GSK2981278 vehicle, and betamethasone valerate 0.1% cream. The test fields on which these treatments will be applied will be identified on stable plaque(s) on the upper extremities, thighs and/or trunk. A blinded evaluator (an investigator or designee) will perform the measurements and assessments whereas an unblinded study staff member (not an evaluator) will perform biopsy collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK2981278, Vehicle, Betamethasone valerate | Experimental | Drug: GSK2981278 0.03%, Drug: GSK2981278 0.1%, Drug: GSK2981278 0.8%, Drug: GSK2981278 4%, Drug: Vehicle, Drug: Betamethasone valerate 0.1%All subjects will receive all six treatments (GSK2981278 ointment 0.03%, 0.1%, 0.8%, 4%, vehicle to match GSK2981278 ointment and betamethasone valerate 0.1% cream); with random assignment of the treatments to 6 test fields on identified stable plaque(s) on the upper extremities, thighs and/or trunk. Subjects will be treated once-daily (except Days 7 and 14) over 19 days (a total of 16 applications) under semi-occlusive conditions (covered by an adhesive non-woven fabric). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years of age and above, at the time of signing the informed consent.
- Subjects with stable plaque psoriasis for >= 6 months, as confirmed by the subject.
- Up to three plaque area(s) sufficient for six test fields. The target lesion(s) should be on the trunk, upper extremities or thighs (excluding hands and skin folds); psoriatic lesion(s) on the knees or elbows are not to be used as a target lesion. It is recommended, but not required, that all selected plaques are symmetrical in location, size and clinical characteristics.
- Plaques to be treated should have a comparable thickness of the Echo Lucent Band (ELB) (as a surrogate for the psoriatic infiltrate thickness) of at least 200 micrometers on Day 1.
- Male:
Key exclusion criteria (20 listed)
- Alanine aminotransferase (ALT) >2xUpper Limit of Normal (ULN) and bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Corrected QT (QTc) interval > 450 milliseconds (msec) or QTc > 480 msec in subjects with Bundle Branch Block. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), and/or machine-read. The QTc should be based on single QTc values of ECG obtained over a brief recording period.
- Any condition that, in the judgement of the investigator, would put the subject at unacceptable risk for the participation in the trial.
- Current evidence of another ongoing or any acute cutaneous infection, history of repeated or chronic significant skin infections (unless irrelevant in the opinion of the investigator, i.e. onychomycosis, labial herpes or other minor diagnosis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK2981278 0.03%GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.03%. Approximately 200 microliters of the GSK2981278 0.03% ointment will be applied topically to the assigned test field once daily. | Drug | GSK2981278, Vehicle, Betamethasone valerate |
| GSK2981278 0.1%GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.1%. Approximately 200 microliters of the GSK2981278 0.1% ointment will be applied topically to the assigned test field once daily. | Drug | GSK2981278, Vehicle, Betamethasone valerate |
| GSK2981278 0.8%GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.8%. Approximately 200 microliters of the GSK2981278 0.8% ointment will be applied topically to the assigned test field once daily. | Drug | GSK2981278, Vehicle, Betamethasone valerate |
| GSK2981278 4%GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 4%. Approximately 200 microliters of the 4% ointment will be applied topically to the assigned test field once daily. | Drug | GSK2981278, Vehicle, Betamethasone valerate |
| VehicleGSK2981278 vehicle will be supplied as a white to off-white ointment containing no drug substance. Approximately 200 microliters of the vehicle will be applied topically to the assigned test field once daily. | Drug | GSK2981278, Vehicle, Betamethasone valerate |
| Betamethasone valerate 0.1%Betamethasone valerate will be supplied as a cream. Approximately 200 microliters of the 0.1% betamethasone valerate cream will be applied topically to the assigned test field once daily. | Drug | GSK2981278, Vehicle, Betamethasone valerate |
Primary outcome
Number of subjects with adverse events
Time frame: From Day 1 until follow-up visit (Day 27)
An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Change from baseline in clinical laboratory parameters
Time frame: Baseline and Days 8, 15, and 19
Change from baseline in heart rate
Time frame: Baseline and Day 19
Change from baseline in systolic and diastolic blood pressure
Time frame: Baseline and Day 19
Change from baseline in oral temperature
Time frame: Baseline and Day 19
Change from baseline in electrocardiogram (ECG)
Time frame: Baseline and Days 15 and 19
Single 12-lead ECGs will be obtained using an ECG machine that automatically calculates heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals.
Reduction in infiltrate thickness of the psoriatic plaque(s) from baseline
Time frame: Baseline (Day 1) and Days 4, 8, 15, and 19
Infiltrate thickness will be measured by 22-MegaHertz high-frequency sonography. Sonography will be done on Days 1, 4, 8, 15, and 19.
1 secondary outcome
Clinical assessment score using a 5- point scale
Time frame: Baseline (Day 1) and Days 4, 8, 15, and 19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Derived from this study: PubMed 29150844Kang EG, Wu S, Gupta A, von Mackensen YL, Siemetzki H, Freudenberg JM, Wigger-Alberti W, Yamaguchi Y. A phase I randomized controlled trial to evaluate safety and clinical effect of topically applied GSK2981278 ointment in a psoriasis plaque test. Br J Dermatol. 2018 Jun;178(6):1427-1429. doi: 10.1111/bjd.16131. Epub 2018 Mar 23. No abstract available.
- Results for study 201465 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK2981278 0.03%, GSK2981278 0.1% and GSK2981278 0.8% in people with Psoriasis, run by GlaxoSmithKline at 1 site in Germany.
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 13 inclusion and 20 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: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects with adverse events (time frame: From Day 1 until follow-up visit (Day 27)). The study lists 7 primary outcomes in all. 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 NCT02548052, which also lists 1 linked publication.
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 15 May 2017.