PsoriasisPhase 1/2NCT00987870
Safety and Efficacy of BFH772 in Psoriasis Patients
A Phase 1/2 study testing BFH772 and calcipotriol/betamethasone in people with Psoriasis and Arthritis, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety after multiple dosing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- BFH772 and calcipotriol/betamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Feb 2010
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable mild to moderate plaque psoriasis (BSA involvement < 10% or PASI < 10
- Category "mild to moderate" on PGA as according to the EMEA (CHMP 2004) (Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis), with or without arthritis
- Diagnosed or history of psoriasis for at least 6 months prior to screening
Who cannot join
- Nonplaque forms of psoriasis
- Drug-induced psoriasis
- Current use of beta blockers
- Congestive heart failure (NYHA >III), QT interval >450msec or poorly controlled diabetes mellitus
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof of Concept Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Topical Administrations of BFH772 in Patients With Psoriasis.
This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety after multiple dosing.
- Being tested
- BFH772, Placebo, calcipotriol/betamethasone
- Keywords
- Stable plaque Psoriasis, inflammatory skin, with or without arthritis
- Medical subject headings
- Psoriasis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFH772Drug
PlaceboDrug
BFH772Drug
PlaceboDrug
calcipotriol/betamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| BFH772 cream 1% | Experimental | Not described Receives: Drug: BFH772 |
| Placebo to BFH772 cream 1% | Placebo comparator | Not described Receives: Drug: Placebo |
| BFH772 ointment 1% | Experimental | Not described Receives: Drug: BFH772 |
| Placebo to BFH772 ointment | Placebo comparator | Not described Receives: Drug: Placebo |
| calcipotriol/betamethasone ointment | Active comparator | Not described Receives: Drug: calcipotriol/betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Plaque PASI score
Measured: 4 weeks
Secondary outcomes (3)
Measure: Local tolerability
Measured: Time Frame: baseline (predose Day 1) and 1h, 3h, 6h after the morning dose, then before each application (morning and evening) until the morning application on Day 5 and then at each visit before the morning application, and at study completion
Measure: BFH772 concentration in plasma
Measured: Day 1: Pre-dose; 4h post dose.
Measure: BFH772 concentration in skin
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 1/2
- 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
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987870
- Sponsor's protocol ID
- CBFH772A2201
- Other IDs
- EUDRACT No. 2008-002795-96
- Status last verified
- Mar 2011
- First submitted
- 30 Sep 2009
- Last updated
- 28 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Topical Administrations of BFH772 in Patients With Psoriasis.
- ClinicalTrials.gov ID
- NCT00987870
- Acronym / sponsor ID
- CBFH772A2201
- Keywords
- Stable plaque Psoriasis, inflammatory skin, with or without arthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (actual)
- First posted
- 1 Oct 2009 (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.
This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety after multiple dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BFH772 cream 1% | Experimental | Drug: BFH772 |
| Placebo to BFH772 cream 1% | Placebo comparator | Drug: Placebo |
| BFH772 ointment 1% | Experimental | Drug: BFH772 |
| Placebo to BFH772 ointment | Placebo comparator | Drug: Placebo |
| calcipotriol/betamethasone ointment | Active comparator | Drug: calcipotriol/betamethasone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable mild to moderate plaque psoriasis (BSA involvement < 10% or PASI < 10
- Category "mild to moderate" on PGA as according to the EMEA (CHMP 2004) (Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis), with or without arthritis
- Diagnosed or history of psoriasis for at least 6 months prior to screening
Key exclusion criteria (5 listed)
- Nonplaque forms of psoriasis
- Drug-induced psoriasis
- Current use of beta blockers
- Congestive heart failure (NYHA >III), QT interval >450msec or poorly controlled diabetes mellitus
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| BFH772 | Drug | BFH772 cream 1% |
| Placebo | Drug | Placebo to BFH772 cream 1% |
| BFH772 | Drug | BFH772 ointment 1% |
| Placebo | Drug | Placebo to BFH772 ointment |
| calcipotriol/betamethasone | Drug | calcipotriol/betamethasone ointment |
Primary outcome
Measure: Plaque PASI score
Time frame: 4 weeks
3 secondary outcomes
Measure: Local tolerability
Time frame: Time Frame: baseline (predose Day 1) and 1h, 3h, 6h after the morning dose, then before each application (morning and evening) until the morning application on Day 5 and then at each visit before the morning application, and at study completion
Measure: BFH772 concentration in plasma
Time frame: Day 1: Pre-dose; 4h post dose.
Measure: BFH772 concentration in skin
Time frame: Week 4
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 28 Mar 2011.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BFH772 and calcipotriol/betamethasone in people with Psoriasis and Arthritis, run by Novartis Pharmaceuticals 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 3 inclusion and 5 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 28 Mar 2011. 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. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Measure: Plaque PASI score (time frame: 4 weeks). 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 28 Mar 2011.