Chronic Plaque PsoriasisPhase 1NCT04221906
Study to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque Test
A Phase 1 study testing BOS-475, Daivonex cream (calcipotriol 0.005%) and Betnesol-V cream (betamethasone 0.1%) in people with Chronic Plaque Psoriasis, run by Boston Pharmaceuticals at 3 sites in Germany.
Trial summary
This study is being conducted to evaluate the safety of topical BOS-475 compared to topically applied comparator formulations and vehicle. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- BOS-475, Daivonex cream (calcipotriol 0.005%) and Betnesol-V cream (betamethasone 0.1%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 3 sitesGermany
- Study dates
- 6 Jan 2020to 6 Mar 2020
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men, or women of non-childbearing potential aged 18-69 years (inclusive)
- Participants with chronic stable plaque psoriasis
- The target lesion(s) should be on the trunk or extremities (excluding palms/soles); psoriatic lesions on the knees or elbows are not to be used as target lesions.
- Willing and able to follow all trial procedures and complete the whole trial
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol
- Willing to refrain from using any topical treatments on the target areas, other than those mandated by the protocol or for protocol procedures
Who cannot join
- Other skin disease or infection that is considered by the investigator to be relevant to the outcome of the trial
- Participants with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica or pustular psoriasis
- Any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar) in the 4 weeks before first treatment and/or during the trial (pretreatment with salicylic acid is permitted on selected plaques; treatment on the face, ears and scalp is also permitted as lesions are not involved in the trial)
- Systemic treatment with antipsoriatics, e.g., corticosteroids, cytostatics, retinoids, dimethylfumarate or apremilast in the three months before first treatment and during the trial
- Systemic treatment with biological treatments: ustekinumab or secukinumab within six months or adalimumab, infliximab, and etanercept within three months before first treatment and during the trial. Any other previously used biologics for treatment of psoriasis should have been washed out for five half lives before first treatment.
- Ultraviolet A (UVA) or B-therapy within four weeks and psoralen and ultraviolet A (PUVA)-therapy within eight weeks before first treatment and during the trial treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g., antimalarial drugs, lithium, beta-blockers, or angiotensin-converting-enzyme (ACE) inhibitors unless on a stable dose for 3 months before trial medication initiation
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- History of malignancy within 5 years prior to dosing, except adequately treated non-invasive skin cancer (basal or squamous cell carcinoma
- Positive urine drug or breath alcohol test results during screening or at Day 1, or history of drug abuse within a year prior to the screening visit
- Excess alcohol consumption within 6 months prior to the trial defined as an average weekly intake of > 14 units for males and females. One unit is equivalent to 8 grams of alcohol: a half-pint (~240 milliliters [mL]) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits
- Blood pressure (BP) >160 millimeters of mercury (mmHg) systolic or >95 mmHg diastolic at screening
- Participation in another clinical trial within the last six months for biological agents, or four weeks for small molecules prior to first treatment in this clinical trial
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Gemeinschaftspraxis Dr. med. Johannes Niesmann und Dr. med. Nick Othlinghaus Hauszentrum im Jahrhunderthaus - Zentrum für klinische Studien
Bochum
bioskin GmbH
Hamburg
Klinische Forschung Schwerin GmbH
Schwerin
About this study
Official title: A Phase Ib, Multi-Center, Randomized, Vehicle- and Comparator-Controlled Trial, Double-Blind for the Investigational Medicinal Products, Observer-Blind for the Comparators to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque Test
This study is being conducted to evaluate the safety of topical BOS-475 compared to topically applied comparator formulations and vehicle.
Read the detailed description
This is a three-center, randomized, placebo- and comparator-controlled, double-blind for the Investigational Medicinal Products (IMPs), observer-blind for the controls, intraindividual comparison of all 6 treatments.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- BOS-475, Active ingredient-free vehicle cream, Daivonex cream (calcipotriol 0.005%), Betnesol-V cream (betamethasone 0.1%)
- Keywords
- BOS-475, antipsoriatic efficacy, safety, psoriasis plaque test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOS-475Drug
topical cream
Active ingredient-free vehicle creamDrug
topical cream
Daivonex cream (calcipotriol 0.005%)Drug
topical cream
Betnesol-V cream (betamethasone 0.1%)Drug
topical cream
| Study group | Role | What they receive |
|---|---|---|
| BOS-475 0.5% | Experimental | Daily application of BOS-475 0.5% Receives: Drug: BOS-475 |
| BOS-475 1% | Experimental | Daily application of BOS-475 1% Receives: Drug: BOS-475 |
| BOS-475 2% | Experimental | Daily application of BOS-475 2% Receives: Drug: BOS-475 |
| Active ingredient-free vehicle cream | Placebo comparator | Daily application of vehicle cream Receives: Drug: Active ingredient-free vehicle cream |
| Daivonex cream | Active comparator | Daily application of Daivonex cream (calcipotriol 0.005%) Receives: Drug: Daivonex cream (calcipotriol 0.005%) |
| Betnesol-V cream (betamethasone 0.1%) | Active comparator | Daily application of Betnesol-V cream (betamethasone 0.1%) Receives: Drug: Betnesol-V cream (betamethasone 0.1%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events (TEAEs)
Measured: up to Day 19
Number of treatment-emergent application site reactions
Measured: up to Day 19
Change from Baseline in systolic and diastolic blood pressure
Measured: Baseline; up to Day 19
Change from Baseline in pulse
Measured: Baseline; up to Day 19
Change from Baseline in respiration
Measured: Baseline; up to Day 19
Change from Baseline in body temperature
Measured: Baseline; up to Day 19
Number of participants with clinically significant physical examination findings
Measured: up to Day 19
Secondary outcomes (4)
Change from Baseline in psoriatic infiltrate thickness on Day 19 (assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-megahertz (MHz) sonography)
Measured: Baseline; Day 19
Change from Baseline in psoriatic infiltrate thickness on Days 8 and 15 (assessed by measurement of the thickness of the EPB of the inflammatory infiltrate using 22-MHz sonography)
Measured: Baseline; Days 8 and 15
Area under the curve (AUC) of change from Baseline in thickness of the EPB of the inflammatory infiltrate
Measured: Baseline; Day 19
Change from Baseline in the test fields compared to the surrounding plaque skin, as an evaluation of the antipsoriatic efficacy by clinical assessment, using a 5-point score
-1 = worsened; 0 = unchanged (no effect); 1 = slight improvement; 2 = clear improvement but not completely healed; 3 = completely healed.
Measured: Baseline; Days 1, 8, 15, and 19 (End of Trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start6 Jan 2020
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaobing Qian, MD, PhD, Study director, Boston Pharmaceuticals, Vice President, Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221906
- Sponsor's protocol ID
- BOS-475-102
- Other IDs
- 2019-002447-17, 2019
- Status last verified
- Nov 2020
- First submitted
- 7 Jan 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Multi-Center, Randomized, Vehicle- and Comparator-Controlled Trial, Double-Blind for the Investigational Medicinal Products, Observer-Blind for the Comparators to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque Test
- ClinicalTrials.gov ID
- NCT04221906
- Acronym / sponsor ID
- BOS-475-102
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- BOS-475, antipsoriatic efficacy, safety, psoriasis plaque test
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boston PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 9 Jan 2020 (actual)
- 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.
This study is being conducted to evaluate the safety of topical BOS-475 compared to topically applied comparator formulations and vehicle.
Detailed description
This is a three-center, randomized, placebo- and comparator-controlled, double-blind for the Investigational Medicinal Products (IMPs), observer-blind for the controls, intraindividual comparison of all 6 treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BOS-475 0.5% | Experimental | Drug: BOS-475Daily application of BOS-475 0.5% |
| BOS-475 1% | Experimental | Drug: BOS-475Daily application of BOS-475 1% |
| BOS-475 2% | Experimental | Drug: BOS-475Daily application of BOS-475 2% |
| Active ingredient-free vehicle cream | Placebo comparator | Drug: Active ingredient-free vehicle creamDaily application of vehicle cream |
| Daivonex cream | Active comparator | Drug: Daivonex cream (calcipotriol 0.005%)Daily application of Daivonex cream (calcipotriol 0.005%) |
| Betnesol-V cream (betamethasone 0.1%) | Active comparator | Drug: Betnesol-V cream (betamethasone 0.1%)Daily application of Betnesol-V cream (betamethasone 0.1%) |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men, or women of non-childbearing potential aged 18-69 years (inclusive)
- Participants with chronic stable plaque psoriasis
- The target lesion(s) should be on the trunk or extremities (excluding palms/soles); psoriatic lesions on the knees or elbows are not to be used as target lesions.
- Willing and able to follow all trial procedures and complete the whole trial
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol
Key exclusion criteria (11 listed)
- Other skin disease or infection that is considered by the investigator to be relevant to the outcome of the trial
- Participants with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica or pustular psoriasis
- Any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar) in the 4 weeks before first treatment and/or during the trial (pretreatment with salicylic acid is permitted on selected plaques; treatment on the face, ears and scalp is also permitted as lesions are not involved in the trial)
- Systemic treatment with antipsoriatics, e.g., corticosteroids, cytostatics, retinoids, dimethylfumarate or apremilast in the three months before first treatment and during the trial
- Systemic treatment with biological treatments: ustekinumab or secukinumab within six months or adalimumab, infliximab, and etanercept within three months before first treatment and during the trial. Any other previously used biologics for treatment of psoriasis should have been washed out for five half lives before first treatment.
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 |
|---|---|---|
| BOS-475topical cream | Drug | BOS-475 0.5%, BOS-475 1%, BOS-475 2% |
| Active ingredient-free vehicle creamtopical cream | Drug | Active ingredient-free vehicle cream |
| Daivonex cream (calcipotriol 0.005%)topical cream | Drug | Daivonex cream |
| Betnesol-V cream (betamethasone 0.1%)topical cream | Drug | Betnesol-V cream (betamethasone 0.1%) |
Primary outcome
Number of treatment-emergent adverse events (TEAEs)
Time frame: up to Day 19
Number of treatment-emergent application site reactions
Time frame: up to Day 19
Change from Baseline in systolic and diastolic blood pressure
Time frame: Baseline; up to Day 19
Change from Baseline in pulse
Time frame: Baseline; up to Day 19
Change from Baseline in respiration
Time frame: Baseline; up to Day 19
Change from Baseline in body temperature
Time frame: Baseline; up to Day 19
Number of participants with clinically significant physical examination findings
Time frame: up to Day 19
4 secondary outcomes
Change from Baseline in psoriatic infiltrate thickness on Day 19 (assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-megahertz (MHz) sonography)
Time frame: Baseline; Day 19
Change from Baseline in psoriatic infiltrate thickness on Days 8 and 15 (assessed by measurement of the thickness of the EPB of the inflammatory infiltrate using 22-MHz sonography)
Time frame: Baseline; Days 8 and 15
Area under the curve (AUC) of change from Baseline in thickness of the EPB of the inflammatory infiltrate
Time frame: Baseline; Day 19
Change from Baseline in the test fields compared to the surrounding plaque skin, as an evaluation of the antipsoriatic efficacy by clinical assessment, using a 5-point score
Time frame: Baseline; Days 1, 8, 15, and 19 (End of Trial)
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 18 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Xiaobing Qian, MD, PhD study director
Boston Pharmaceuticals, Vice President, Clinical Development
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BOS-475, Daivonex cream (calcipotriol 0.005%) and Betnesol-V cream (betamethasone 0.1%) in people with Chronic Plaque Psoriasis, run by Boston Pharmaceuticals at 3 sites 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 6 inclusion and 11 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 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 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 treatment-emergent adverse events (TEAEs) (time frame: up to Day 19). 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?
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 18 Nov 2020.