PsoriasisPhase 2NCT01208090
ACT-128800 in Patients With Moderate to Severe Chronic Plaque Psoriasis
A Phase 2 study testing ACT-128800 in people with Psoriasis, run by Actelion at 67 sites in 17 countries.
Trial summary
This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- 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
- 326 participants
- Where
- 67 sitesin 17 countries
- Study dates
- 31 Oct 2010to 30 Nov 2012
- 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 aged 18 to 60 years (inclusive) with moderate to severe chronic plaque psoriasis who require systemic treatment.
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
67 sites in 17 countries.
67 sites in 17 countries
Italy8 sites
Clinical Investigative Site 2315
Ancona, 60020
Clinical Investigative Site 2303
Bergamo, 24128
Clinical Investigative Site 2307
Bologna, 40138
Clinical Investigative Site 2317
Genova, 16132
Clinical Investigative Site 2309
L’Aquila, 67100
Clinical Investigative Site 2310
Pisa, 56126
Clinical Investigative Site 2304
Roma, 00133
Clinical Investigative Site 2316
Rome, 00168
Romania8 sites
Clinical Investigative Site 2608
Bucharest, 011461
Clinical Investigative Site 2601
Bucharest, 020125
Clinical Investigative Site 2604
Cluj-Napoca, 400006
Clinical Investigative Site 2603
Iași, 700368
Clinical Investigative Site 2606
Oradea, 410167
Clinical Investigative Site 2607
Sibiu, 550245
Clinical Investigative Site 2605
Târgu Mureş, 540342
Clinical Investigative Site 2602
Timișoara, 300074
France7 sites
Clinical Investigative Site 1704
Bordeaux, 86021
Clinical Investigative Site 1701
Nice, 06202
Clinical Investigative Site 1707
Paris, 75475
Clinical Investigative Site 1710
Paris, 75877
Clinical Investigative Site 1705
Pierre-Bénite, 69310
Clinical Investigative Site 1703
Poitiers, 86021
Clinical Investigative Site 1702
Saint-Etienne, 42055
Bulgaria6 sites
Clinical Investigative Site 1205
Pleven, 5800
Clinical Investigative Site 1204
Plovdiv, 4002
Clinical Investigative Site 1202
Sofia, 1431
Clinical Investigative Site 1201
Sofia, 1606
Clinical Investigative Site 1203
Sofia, 1606
Clinical Investigative Site 1206
Stara Zagora, 6000
Hungary6 sites
Clinical Investigative Site 2002
Budapest, 1085
Clinical Investigative Site 2001
Debrecen, 4012
Clinical Investigative Site 2006
Miskolc, 3529
Clinical Investigative Site 2005
Pécs, 7624
Clinical Investigative Site 2003
Szeged, 6720
Clinical Investigative Site 2004
Veszprém, 8200
Austria5 sites
Clinical Investigative Site 1006
Feldkirch, 6807
Clinical Investigative Site 1002
Graz, 8036
Clinical Investigative Site 1004
Sankt Pölten, 3100
Clinical Investigative Site 1007
Vienna, 1130
Clinical Investigative Site 1001
Vienna, A-1090
Czechia4 sites
Clinical Investigative Site 1402
Hradec Králové, 50005
Clinical Investigative Site 1405
Nový Jičín, 74101
Clinical Investigative Site 1406
Pardubice, 53203
Clinical Investigative Site 1401
Prague, 10034
Slovakia4 sites
Clinical Investigative Site 2704
Banská Bystrica, 97517
Clinical Investigative Site 2701
Košice, 04166
Clinical Investigative Site 2705
Kosice-Saca, 04015
Clinical Investigative Site 2708
Trnava, 91775
Spain4 sites
Clinical Investigative Site 2901
Barcelona, 08025
Clinical Investigative Site 2907
Las Palmas de Gran Canaria
Clinical Investigative Site 2902
Madrid, 28041
Clinical Investigative Site 2904
Madrid, 28922
Belgium3 sites
Clinical Investigative Site 1103
Brussels, 1200
Clinical Investigative Site 1102
Edegem, 2650
Clinical Investigative Site 1101
Liège, 4000
Denmark2 sites
Clinical Investigative Site 1502
Copenhagen, 2400
Clinical Investigative Site 1504
Roskilde, 4000
Sweden2 sites
Clinical Investigative Site 3001
Stockholm, 17176
Clinical Investigative Site 3006
Umeå, 90185
Switzerland2 sites
Clinical Investigative Site 3101
Lausanne, 1011
Clinical Investigative Site 3103
Zurich, 8091
Ukraine2 sites
Clinical Investigative Site 3512
Poltava, 36038
Clinical Investigative Site 3514
Zaporizhia, 69063
United Kingdom2 sites
Clinical Investigative Site 3306
Dundee, DD1 9SY
Clinical Investigative Site 3304
London, E11 1NR
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety & Tolerability of Two Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered up to Twenty-eight Weeks in Patients With Moderate to Severe Chronic Plaque Psoriasis
This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.
- Conditions
- Psoriasis
- Being tested
- ACT-128800, Placebo
- Keywords
- psoriasis, chronic plaque psoriasis, Moderate to severe chronic plaque psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-128800Drug
ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
PlaceboDrug
ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Investigational drug - Dose 1 | Experimental | Not described Receives: Drug: ACT-128800 |
| Investigational drug - Dose 2 | Experimental | Not described Receives: Drug: ACT-128800 |
| Matching placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.
Measured: Baseline to week 16
Secondary outcomes (1)
Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16.
Measured: Baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study start31 Oct 2010
- Primary completion31 Oct 2012
- Study completion30 Nov 2012
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.
- 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
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Actelion Pharmaceuticals, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208090
- Sponsor's protocol ID
- AC-058A201
- Status last verified
- Mar 2025
- First submitted
- 22 Sep 2010
- Last updated
- 30 Mar 2025
- Results posted
- No
Publications
Vaclavkova A, Chimenti S, Arenberger P, Hollo P, Sator PG, Burcklen M, Stefani M, D'Ambrosio D. Oral ponesimod in patients with chronic plaque psoriasis: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet. 2014 Dec 6;384(9959):2036-45. doi: 10.1016/S0140-6736(14)60803-5. Epub 2014 Aug 10.
PubMed 25127208
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety & Tolerability of Two Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered up to Twenty-eight Weeks in Patients With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01208090
- Acronym / sponsor ID
- AC-058A201
- Conditions
- Psoriasis
- Keywords
- psoriasis, chronic plaque psoriasis, Moderate to severe chronic plaque psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2010 (actual)
- Primary completion
- 31 Oct 2012 (actual)
- Study completion
- 30 Nov 2012 (actual)
- First posted
- 23 Sep 2010 (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 two doses of ACT 128800 in patients with moderate-to-severe chronic 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational drug - Dose 1 | Experimental | Drug: ACT-128800 |
| Investigational drug - Dose 2 | Experimental | Drug: ACT-128800 |
| Matching placebo | 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 aged 18 to 60 years (inclusive) with moderate to severe chronic plaque psoriasis who require systemic treatment.
Key exclusion criteria (4 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 (Dose 1 or Dose 2) or matching placebo administered orally once daily | Drug | Investigational drug - Dose 1, Investigational drug - Dose 2 |
| PlaceboACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily | Drug | Matching placebo |
Primary outcome
Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.
Time frame: Baseline to week 16
1 secondary outcome
Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16.
Time frame: Baseline to week 16
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 30 Mar 2025.
- Derived from this study: PubMed 25127208Vaclavkova A, Chimenti S, Arenberger P, Hollo P, Sator PG, Burcklen M, Stefani M, D'Ambrosio D. Oral ponesimod in patients with chronic plaque psoriasis: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet. 2014 Dec 6;384(9959):2036-45. doi: 10.1016/S0140-6736(14)60803-5. Epub 2014 Aug 10.
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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.
Actelion Pharmaceuticals study director
Actelion
67 sites in 17 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 Psoriasis, run by Actelion at 67 sites in 17 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 4 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 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in Italy, Romania, France, Bulgaria, Hungary and 12 more countries. 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?
Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (time frame: Baseline to week 16). 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 NCT01208090, 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 30 Mar 2025.