PsoriasisPhase 2NCT00504270
A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.
A Phase 2 study testing RG3421 120mg and RG3421 20mg in people with Psoriasis, run by Hoffmann-La Roche at 15 sites in United States.
Trial summary
This study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3 treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or c)placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- RG3421 120mg and RG3421 20mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 15 sitesUnited States
- Study dates
- Jul 2007to 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 18-70 years of age;
- medically stable, moderate to severe chronic plaque psoriasis.
Who cannot join
- any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions;
- confounding or concomitant condition or treatment.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Study site
Albuquerque, New Mexico, 87106
Study site
Alpharetta, Georgia, 30005
Study site
East Windsor, New Jersey, 08520
Study site
Galveston, Texas, 77550
Study site
Hot Springs, Arkansas, 71913
Study site
Little Rock, Arkansas, 72205
Study site
Nashville, Tennessee, 37215
Study site
New York, New York, 10016
Study site
New York, New York, 10029
Study site
Providence, Rhode Island, 02903
Study site
San Antonio, Texas, 78229
Study site
Santa Monica, California, 90404
Study site
Stony Brook, New York, 11790
Study site
Webster, Texas, 77598
Study site
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized, Placebo-controlled Dose-ranging Pilot Study to Assess the Effect on Clinical Response, and the Safety and Tolerability of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis
This study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3 treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or c)placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
- Conditions
- Psoriasis
- Being tested
- Placebo, RG3421 120mg, RG3421 20mg
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
po daily
RG3421 120mgDrug
120mg po daily
RG3421 20mgDrug
20mg po daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | po daily Receives: Drug: Placebo |
| RG3421 120mg | Experimental | 120mg po daily Receives: Drug: RG3421 120mg |
| RG3421 20mg | Experimental | 20mg po daily Receives: Drug: RG3421 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs), laboratory parameters, pharmacokinetics
Measured: Throughout study
Secondary outcomes (1)
Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionSep 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 PsoriasisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504270
- Sponsor's protocol ID
- NS20454
- Status last verified
- Nov 2016
- First submitted
- 18 Jul 2007
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Dose-ranging Pilot Study to Assess the Effect on Clinical Response, and the Safety and Tolerability of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00504270
- Acronym / sponsor ID
- NS20454
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Jul 2007 (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 investigate the safety, efficacy and pharmacokinetics of R3421 in patients with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3 treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or c)placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebopo daily |
| RG3421 120mg | Experimental | Drug: RG3421 120mg120mg po daily |
| RG3421 20mg | Experimental | Drug: RG3421 20mg20mg po daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients, 18-70 years of age;
- medically stable, moderate to severe chronic plaque psoriasis.
Key exclusion criteria (2 listed)
- any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions;
- confounding or concomitant condition or 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 |
|---|---|---|
| Placebopo daily | Drug | Placebo |
| RG3421 120mg120mg po daily | Drug | RG3421 120mg |
| RG3421 20mg20mg po daily | Drug | RG3421 20mg |
Primary outcome
Adverse events (AEs), laboratory parameters, pharmacokinetics
Time frame: Throughout study
1 secondary outcome
Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers
Time frame: Throughout study
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 2 Nov 2016.
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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.
Clinical Trials study chair
Hoffmann-La Roche
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RG3421 120mg and RG3421 20mg in people with Psoriasis, run by Hoffmann-La Roche at 15 sites in United States.
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 2 inclusion and 2 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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?
Adverse events (AEs), laboratory parameters, pharmacokinetics (time frame: Throughout study). 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 2 Nov 2016.