Plaque PsoriasisPhase 1NCT00871598
BTT1023 in Psoriasis
A Phase 1 study testing BTT1023 in people with Plaque Psoriasis, run by Biotie Therapies Corp. at 5 sites in Germany.
Trial summary
Patients with plaque psoriasis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- BTT1023
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 5 sitesGermany
- Study dates
- Mar 2009to Aug 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Plaque psoriasis affecting at least 8% of the body surface area and scoring 8 or higher in the psoriasis area and severity index
Who cannot join
- Seropositive for infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus; Tuberculosis; Acute systemic infection;
- Treatment with a monoclonal antibody therapy within 12 weeks prior to study entry;
- An absolute indication for a known effective treatment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Biotie investigational site
Berlin, State of Berlin, 12627
Biotie investigational site
Berlin, State of Berlin, 14050
Biotie investigational site
Dresden, Dresden, 01067
Biotie Investigational Site
Görlitz, 02826
Biotie investigational site
Leipzig, Leipzig, 04103
About this study
Official title: A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Repeated Intravenous Doses of BTT-1023 in Patients With Plaque Psoriasis - a Double-blind Randomized Placebo-controlled Sequential Group Trial
Patients with plaque psoriasis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.
- Conditions
- Plaque Psoriasis
- Being tested
- BTT1023, Placebo
- Keywords
- plaque psoriasis, BTT1023, safety, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTT1023Drug
intravenous, three infusions over three weeks
PlaceboDrug
intravenous, three infusions over three weeks
BTT1023Drug
Test challenge
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Single 0.3 | Experimental | Not described Receives: Drug: BTT1023 |
| Repeat 1.0 | Experimental | Not described Receives: Drug: BTT1023 |
| Repeat 2.0 | Experimental | Not described Receives: Drug: BTT1023 |
| Repeat 4.0 | Experimental | Not described Receives: Drug: BTT1023 |
| Repeat 8.0 | Experimental | Not described Receives: Drug: BTT1023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 12 weeks
Plasma concentrations of BTT1023
Measured: 12 weeks
Secondary outcomes (1)
Change in Psoriasis Area and Severity Index (PASI)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotie Therapies Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871598
- Sponsor's protocol ID
- BTT12-CD016
- Status last verified
- Nov 2010
- First submitted
- 27 Mar 2009
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Repeated Intravenous Doses of BTT-1023 in Patients With Plaque Psoriasis - a Double-blind Randomized Placebo-controlled Sequential Group Trial
- ClinicalTrials.gov ID
- NCT00871598
- Acronym / sponsor ID
- BTT12-CD016
- Conditions
- Plaque Psoriasis
- Keywords
- plaque psoriasis, BTT1023, safety, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Biotie Therapies Corp.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 30 Mar 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.
Patients with plaque psoriasis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Single 0.3 | Experimental | Drug: BTT1023 |
| Repeat 1.0 | Experimental | Drug: BTT1023 |
| Repeat 2.0 | Experimental | Drug: BTT1023 |
| Repeat 4.0 | Experimental | Drug: BTT1023 |
| Repeat 8.0 | Experimental | Drug: BTT1023 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Plaque psoriasis affecting at least 8% of the body surface area and scoring 8 or higher in the psoriasis area and severity index
Key exclusion criteria (3 listed)
- Seropositive for infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus; Tuberculosis; Acute systemic infection;
- Treatment with a monoclonal antibody therapy within 12 weeks prior to study entry;
- An absolute indication for a known effective 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 |
|---|---|---|
| BTT1023intravenous, three infusions over three weeks | Drug | Repeat 1.0, Repeat 2.0, Repeat 4.0, Repeat 8.0 |
| Placebointravenous, three infusions over three weeks | Drug | Placebo |
| BTT1023Test challenge | Drug | Single 0.3 |
Primary outcome
Adverse events
Time frame: 12 weeks
Plasma concentrations of BTT1023
Time frame: 12 weeks
1 secondary outcome
Change in Psoriasis Area and Severity Index (PASI)
Time frame: 12 weeks
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 16 Nov 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 BTT1023 in people with Plaque Psoriasis, run by Biotie Therapies Corp. at 5 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 1 inclusion and 3 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 16 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Adverse events (time frame: 12 weeks). The study lists 2 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 16 Nov 2010.