PsoriasisPhase 2NCT00716144

Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis

A Phase 2 study testing Talarozole in people with Psoriasis, run by Stiefel, a GSK Company at 22 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Eligible subjects will be randomly assigned to one of three dose regimens of oral R115866 or placebo for the treatment of severe plaque psoriasis for 12 twelve weeks. The safety and efficacy of R115866 will be evaluated during the treatment period and the 8-week post treatment follow-up period. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: Talarozole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 176 participants
Where: 22 sitesin 5 countries
Study dates: 1 Jun 2006to 1 May 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Plaque Psoriasis with PASI greater than or equal to 10
Male or a female who was NOT of childbearing potential (i.e., post- menopausal for greater than 12 months or had a complete hysterectomy);

Who cannot join

Spontaneously improving or rapidly deteriorating plaque psoriasis
Guttate, pustular, erythrodermic, or other non-plaque form of psoriasis
Subject was under treatment for a heart disorder or had a history of cardiovascular disease (excluding effectively controlled hypertension)
Any acute psychiatric condition, including an increased risk for suicide attempt, based on medical and psychiatric history
Previous use of a psoriasis vaccine or had participated in an investigational study of a psoriasis vaccine
Previous use of systemic immunomodulatory therapy known to affect psoriasis and to typically decrease immune cell populations

Show all 10Show fewer

Previous use of any systemic immunomodulatory therapy known to affect psoriasis and NOT typically to decrease immune cell populations
Previous use of any photo-therapy (including laser), photo-chemotherapy, or systemic psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids, or cyclosporine) within the previous four weeks
Pregnant or a nursing mother
Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, cancer (except non-melanoma skin cancer), a positive test for human immunodeficiency virus (HIV), a history indicating adrenal cortex dysfunction

Trial locations and contacts

22 sites in 5 countries.

Country

City, postcode or hospital

22 sites in 5 countries

Russia7 sites

GSK Investigational Site
Korolyov
GSK Investigational Site
Lipetsk
GSK Investigational Site
Moscow
GSK Investigational Site
Saint Petersburg
GSK Investigational Site
Smolensk
GSK Investigational Site
Velikiy Novgorod
GSK Investigational Site
Yaroslavl

Other trials in Russia

Germany6 sites

GSK Investigational Site
Augsburg
GSK Investigational Site
Berlin
GSK Investigational Site
Dresden
GSK Investigational Site
Frankfurt
GSK Investigational Site
Hamburg
GSK Investigational Site
Hansestadt Salzwedel

Other trials in Germany

United Kingdom6 sites

GSK Investigational Site
Aberdeen
GSK Investigational Site
Amersham
GSK Investigational Site
Coventry
GSK Investigational Site
Glasgow
GSK Investigational Site
Manchester
GSK Investigational Site
Norwich

Other trials in United Kingdom

Netherlands2 sites

GSK Investigational Site
Maastricht
GSK Investigational Site
Nijmegen

Other trials in Netherlands

Ireland1 site

GSK Investigational Site
Cork

Other trials in Ireland

About this study

Official title: A Randomized, Evaluator-Blind, Placebo-Controlled, Parallel-Group Dose-Ranging Study of the Safety and Efficacy of Oral R115866 and R115866 Placebo in the Treatment of Plaque Psoriasis

Conditions: Psoriasis
Being tested: Talarozole
Keywords: Psoriasis
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TalarozoleDrug
Also called Rambazole, R115866
Oral Capsule Once Daily

Study groups in NCT00716144
Study group	Role	What they receive
A	Active comparator	Talarozole 0.5 mg Receives: Drug: Talarozole
B	Active comparator	Talarozole 1.0 mg Receives: Drug: Talarozole
C	Active comparator	Talarozole 2.0 mg Receives: Drug: Talarozole
D	Placebo comparator	Talarozole matching Placebo Receives: Drug: Talarozole

What is being measured

The primary outcome is the main question the study is designed to answer.

Psoriasis Area Severity Index (PASI)75 Success at Visit 6
PASI75 success at Visit 6 was defined as number of participants who achieved at least 75% reduction in PASI scores at Visit 6 compared to Visit 2 (Baseline). The PASI score was determined through evaluation of body surface area (BSA) covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.
Measured: Week 12 (Visit 6)

Secondary outcomes (3)

PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit
PASI50 success was defined as number of participants who achieved at least 50% reduction in PASI scores at each post baseline visit (Visit 3 to 8) compared to Visit 2 (Baseline). The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.
Measured: Week 1 to Week 20 (Visit 3 to Visit 8)
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
The IGA was used to assess the overall severity of a participant's plaque psoriasis at a particular time point and the evaluation took into consideration the three individual characteristics of plaque psoriasis (scaling, plaque elevation, and erythema). The IGA was recorded using a scale that ranged from 0 (clear), 1 = almost clear, 2 = mild, 3 = moderate to 4 (severe) in whole-unit increments; higher scores indicating worse psoriasis. Investigators did not refer to previous evaluations when conducting the IGA assessment. At every study visit, the investigator evaluated each participant's plaque psoriasis and recorded the one integer grade that best described the average, overall severity of the condition. Investigators were trained not to refer to previous assessments of the IGA, and not to base the IGA scores on any component of the PASI. Individual body regions were not assessed (as in the PASI), but rather a global evaluation for each participant at each visit was determined.
Measured: Week 1 to Week 20 (Visit 3 to Visit 8)
PASI75 at Each Post Baseline Visit Except Visit 6
PASI75 success was defined as number of participants who achieved at least 75% reduction in PASI scores at each post baseline visit (Visit 3 to Visit 8) except Visit 6. The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.
Measured: Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20061 May 2007

First posted16 Jul 2008 (estimated)
Study start1 Jun 2006
Primary completion1 May 2007
Study completion1 May 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00716144
Sponsor's protocol ID: BT0720-201-INT
Status last verified: May 2017
First submitted: 15 Jul 2008
Last updated: 29 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Evaluator-Blind, Placebo-Controlled, Parallel-Group Dose-Ranging Study of the Safety and Efficacy of Oral R115866 and R115866 Placebo in the Treatment of Plaque Psoriasis
ClinicalTrials.gov ID: NCT00716144
Acronym / sponsor ID: BT0720-201-INT
Conditions: Psoriasis
Keywords: Psoriasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: 1 Jun 2006
Primary completion: 1 May 2007 (actual)
Study completion: 1 May 2007 (actual)
First posted: 16 Jul 2008 (estimated)
Results: Posted 29 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
A	Active comparator	Drug: TalarozoleTalarozole 0.5 mg
B	Active comparator	Drug: TalarozoleTalarozole 1.0 mg
C	Active comparator	Drug: TalarozoleTalarozole 2.0 mg
D	Placebo comparator	Drug: TalarozoleTalarozole matching Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Plaque Psoriasis with PASI greater than or equal to 10
Male or a female who was NOT of childbearing potential (i.e., post- menopausal for greater than 12 months or had a complete hysterectomy);

Key exclusion criteria (10 listed)

Spontaneously improving or rapidly deteriorating plaque psoriasis
Guttate, pustular, erythrodermic, or other non-plaque form of psoriasis
Subject was under treatment for a heart disorder or had a history of cardiovascular disease (excluding effectively controlled hypertension)
Any acute psychiatric condition, including an increased risk for suicide attempt, based on medical and psychiatric history
Previous use of a psoriasis vaccine or had participated in an investigational study of a psoriasis vaccine

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
TalarozoleAlso: Rambazole, R115866Oral Capsule Once Daily	Drug	A, B, C, D

Primary outcome

Psoriasis Area Severity Index (PASI)75 Success at Visit 6
Time frame: Week 12 (Visit 6)
PASI75 success at Visit 6 was defined as number of participants who achieved at least 75% reduction in PASI scores at Visit 6 compared to Visit 2 (Baseline). The PASI score was determined through evaluation of body surface area (BSA) covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.

3 secondary outcomes

PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit
Time frame: Week 1 to Week 20 (Visit 3 to Visit 8)
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Time frame: Week 1 to Week 20 (Visit 3 to Visit 8)
PASI75 at Each Post Baseline Visit Except Visit 6
Time frame: Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6)

Results and safety

Results posted to the registry on 29 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	41	32
R115866 0.5 mg	45	38
R115866 1.0 mg	45	33
R115866 2.0 mg	45	33

Primary outcome: Psoriasis Area Severity Index (PASI)75 Success at Visit 6

Time frame: Week 12 (Visit 6). Number. Unit: Participants

Measure	Placebo n = 41	R115866 0.5 mg n = 45	R115866 1.0 mg n = 45	R115866 2.0 mg n = 45
Value	4	7	4	5

Placebo vs R115866 0.5 mg vs R115866 1.0 mg vs R115866 2.0 mg: p = 0.884, Cochran-Armitage Trend Test

Population analysed: Modified Intent-to-Treat (MITT) population. MITT population comprised of all randomized participants who took study medication and provided post-Visit 2 efficacy data (i.e., had one on-therapy follow-up visit).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 41 (2.4%)	20 of 41 (48.8%)	0 of 41
R115866 0.5 mg	1 of 45 (2.2%)	34 of 45 (75.6%)	0 of 45
R115866 1.0 mg	0 of 45 (0%)	38 of 45 (84.4%)	0 of 45
R115866 2.0 mg	0 of 45 (0%)	37 of 45 (82.2%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

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.

GSK Clinical Trials study director

GlaxoSmithKline

22 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 Talarozole in people with Psoriasis, run by Stiefel, a GSK Company at 22 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 2 inclusion and 10 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 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Russia, Germany, United Kingdom, Netherlands, Ireland. 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?

Yes. Results are posted in the registry (first posted 29 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Severity Index (PASI)75 Success at Visit 6 (time frame: Week 12 (Visit 6)). 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 NCT00716144.

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 29 Jan 2018.