Plaque PsoriasisPhase 2NCT00852670
ACT-128800 in Psoriasis
A Phase 2 study testing ACT-128800 in people with Plaque Psoriasis, run by Actelion at 14 sites in 5 countries.
Trial summary
This study will assess the efficacy, safety, and tolerability of ACT-128800 in subjects with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- ACT-128800
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 14 sitesin 5 countries
- Study dates
- Oct 2008to Sep 2009
- Phase
- Phase 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult males and females with moderate to severe plaque psoriasis who require systemic treatment and for whom participation in a placebo-controlled study of an investigational drug is justified.
Who cannot join
- Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than psoriasis.
- Systemic or topical treatments for psoriasis other than emollients.
- Ongoing bacterial, viral or fungal infections.
- History or presence of malignancy.
- Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Germany4 sites
Klinik für Dermatologie Venerologie und Allergologie
Berlin, 10117
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Department of Dermatology University Hospital Johannes Gutenberg-University Mainz
Mainz, 55131
University Clinic Münster Clinic and Policlinic for skin diseases
Münster, 48149
Hungary4 sites
Semmelweis Universtity Dept. dermato-venerology and skin oncology
Budapest, 1085
UNIVERSITY OF DEBRECEN Department of dermatology
Debrecen, 4012
University of Szeged Department of dermatology and allergology
Szeged, 6720
Veszprem County Csolnoky Ferenc Hospital Dermatology Department
Veszprém, 8200
France3 sites
Departement de Pneumologie/ Unité Immunologie Clinique Allergie- Centre Hospitalier Lyon sud
Lyon, 69000
CHU de Nice-Hôpital de l'Archet 2 / Service de dermatologie
Nice, 6202
Dermatologie, Hôpital Purpan Universtité Paul Sabatier
Toulouse, 31000
Austria2 sites
Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie
Graz, 8036
University Klinik of Vienna
Vienna, 1090
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIa Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800, an S1P1 Receptor Agonist, Administered for 6 Weeks to Subjects With Moderate to Severe Chronic Plaque Psoriasis
This study will assess the efficacy, safety, and tolerability of ACT-128800 in subjects with moderate to severe plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- ACT-128800, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-128800Drug
ACT-128800 administered orally once daily
PlaceboDrug
Matching placebo capsules administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: ACT-128800 |
| B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit.
Measured: Baseline to week 6
Secondary outcomes (1)
"Clear - almost clear" Physician Global Assessment (PGA) at Week 6 visit.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionJul 2009
- Study completionSep 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Albrecht Georg Schmidt, MD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852670
- Sponsor's protocol ID
- AC-058A200
- Status last verified
- Nov 2009
- First submitted
- 26 Feb 2009
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIa Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800, an S1P1 Receptor Agonist, Administered for 6 Weeks to Subjects With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00852670
- Acronym / sponsor ID
- AC-058A200
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Feb 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 assess the efficacy, safety, and tolerability of ACT-128800 in subjects with moderate to severe plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ACT-128800 |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult males and females with moderate to severe plaque psoriasis who require systemic treatment and for whom participation in a placebo-controlled study of an investigational drug is justified.
Key exclusion criteria (5 listed)
- Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than psoriasis.
- Systemic or topical treatments for psoriasis other than emollients.
- Ongoing bacterial, viral or fungal infections.
- History or presence of malignancy.
- Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.
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 |
|---|---|---|
| ACT-128800ACT-128800 administered orally once daily | Drug | A |
| PlaceboMatching placebo capsules administered orally once daily | Drug | B |
Primary outcome
Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit.
Time frame: Baseline to week 6
1 secondary outcome
"Clear - almost clear" Physician Global Assessment (PGA) at Week 6 visit.
Time frame: Week 6
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 13 Nov 2009.
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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.
Albrecht Georg Schmidt, MD study director
Actelion
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACT-128800 in people with Plaque Psoriasis, run by Actelion at 14 sites in 5 countries.
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 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 13 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Hungary, France, Austria, Serbia. 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 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?
Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit. (time frame: Baseline to week 6). 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 13 Nov 2009.