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Plaque PsoriasisPhase 2NCT01230138

Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis

A Phase 2 study testing FP187 in people with Plaque Psoriasis, run by Forward-Pharma GmbH at 2 sites in Germany.

Completed

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

Official record
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Trial summary

The purpose of this trial is to investigate the efficacy and safety of different doses and dose administrations of FP187 compared to a placebo treatment in patients with moderate to severe plaque psoriasis. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
FP187
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
252 participants
Where
2 sitesGermany
Study dates
Sep 2010to May 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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients of either sex at least 18 years of age
  • A clinical diagnosis of plaque psoriasis defined as skin areas with erythema, induration and scaling, with a body surface area of no less than 10% and in total to be scoring at least 10 on the PASI scale
  • The psoriasis disease have been stable for at least 6 months at randomization
  • Signed and dated informed consent
  • Sexually active females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a highly effective (failure rate < 1%) medically accepted contraceptive method during the trial as well as one month after trial is finished such as:
  • Systemic contraceptive (oral, implant, injection),
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  • Intrauterine device (IUD) inserted for at least one month prior to study entrance
  • Willingness and ability to comply with the trial procedures
  • Patient is beside the psoriasis disease in good general health in the opinion of the Investigator, as determined by medical history, physical examination, vital signs and clinical laboratory parameters (hematology, biochemistry and urinalysis).

Who cannot join

  • Female patients who are pregnant or breast-feeding or planning to become pregnant up to 7 months from treatment start as well as male patients plan-ning pregnancy with their partner up to 7 months from treatment start or practise unprotected sexual relationship up to 7 months from treatment start
  • Known allergy to any of the constituents of the product being tested
  • Pustular forms of psoriasis, erythrodermic or guttate psoriasis
  • Known immunosuppressive diseases (e.g., AIDS/HIV)
  • Presence of another serious or progressive disease which, according to the Investigator may interfere with treatment outcome
  • Active skin disease such as atopic dermatitis, rosacea, lupus erythematosus, or other inflammatory or infectious skin disease which, according to the Investigator may interfere with treatment outcome
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  • Use of topical medical treatment or UVB treatment - Use of systemic anti-psoriatic treatment preceding the baseline visit Methotrexate, cyclosporine, steroids or PUVA treatment within x weeks; Biological treatment (efalizumab, adalimumab, infliximab, etanercept) within xx weeks; Acitretin within x months; Treatment with Fumaderm® or other DMF containing products during past xx weeks prior to baseline visit; Discontinuation of previous treatment with Fumaderm® or other DMF containing products due to lack of efficacy or side effects;
  • Has within the past x weeks prior to baseline visit been treated with drugs influencing the course of the psoriasis such as antimalarial drugs, beta-blockers or lithium
  • Has a relevant clinical history of stomach or intestinal problems (eg gastritis or peptic ulcer within the last 10 years )
  • Has liver enzyme measures (AST, ALT, Gamma-GT) higher than 2x UNL)
  • Has an estimated Creatinine Clearance: < xx ml/min
  • Has leucopenia (leukocyte count < x/mm3) or eosinophilia (count >x/µl) or lymphopenia (count < x/nl).
  • Has protein in the urine test at screening or baseline visit
  • Participation in another clinical trial during the last month preceding the baseline visit or participation in a trial with treatment of biologicals within x months prior to baseline visit
  • Patients who are involved in the organisation of the clinical investigation or are in any way dependant on the investigator or sponsor

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Dermatological Dept., Uniklinikum, TU-Dresden

    Dresden, 01307

  • SCIderm

    Hamburg, 20354

Other trials in Germany

About this study

Official title: A Randomised, Double Blind, Placebo Controlled Efficacy and Safety Trial of Different Doses/Dose Regimens of FP187 Compared to Placebo in Moderate to Severe Plaque Psoriasis (Pivotal Registration Study)

The purpose of this trial is to investigate the efficacy and safety of different doses and dose administrations of FP187 compared to a placebo treatment in patients with moderate to severe plaque psoriasis.

Read the detailed description

The trial tests two different dose levels and two different daily dosing schedules (twice daily (BID) and three times daily (TID))over 20 weeks of treatment. Key is effect as measured by achievement of a 75% reduction in PASI after 20 weeks and safety monitored by adverse events and safety lab.

There are 3 active arms:

  1. FP-187 at a daily dose of 750mg divided in three doses (250mg TID)
  2. FP-187 at a daily dose of 750mg divided in two doses (375mg BID)
  3. FP-187 at a daily dose of 500mg divided in two doses (250mg BID) and 1 placebo arm.

An additional open (flexible dosing) treatment arm has been amended to the trial

Being tested
Placebo, FP187

What participants receive

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

  • PlaceboDrug

    Also called Placebo of FP187

    Placebo tablets

  • FP187Drug

    High daily dose of 750mg administered as 250mg TID

  • FP187Drug

    High daily dose of 750mg administered as 375mg BID

  • FP187Drug

    Low daily dose of 500mg FP187 administered as 250mg BID

  • FP187Drug

    Oral tablets, up to 3 times daily for 20 weeks.

Study groups in NCT01230138
Study groupRoleWhat they receive
FP187 - TIDExperimentalFP187 250mg TID (total daily dose of 750mg)
Receives: Drug: FP187
FP187- BIDExperimentalFP187 375mg BID (total daily dose of 750mg)of 750mg administered as 375mg BID
Receives: Drug: FP187
FP187-LD-BIDExperimentalFP187 250mg BID (total daily dose of 500mg)
Receives: Drug: FP187
PlaceboPlacebo comparatorPlacebo treatment
Receives: Drug: Placebo
Open, flexible dosing treatment armExperimentalOpen treatment using a flexible dosing schedule for 8 weeks with maximum dose of 750mg FP187 and with a total dosing of 20 weeks. All investigations following same schedule.
Receives: Drug: FP187

What is being measured

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

  1. Proportion of patients achieving PASI 75 compared to placebo

    Proportion of patients achieving PASI75 (a reduction in the PASI score of 75% or more)

    Measured: After 20 weeks of treatment

Secondary outcomes (9)

  1. PASI 75

    Proportion of patients achieving PASI75 (a reduction of the PASI score of 75% or more compared to baseline)

    Measured: At week 4, 8, 12 and 16

  2. PASI 50

    Proportion of patients who achieves PASI 50 (a reduction of the PASI score of 50% or more compared to baseline)

    Measured: At week 4, 8, 12, 16 and 20

  3. PASI 90

    Proportion of patients achieving PASI90 (a reduction of the PASI score of 90% or more compared to baseline

    Measured: At week 4, 8, 12, 16 and 20

  4. PGA (Physicians Global Assessment)

    On a 5-point scale from 0 (abscence or very mild disease) to 4 (very severe disease) proportion of patients being responders - defined as patients achieving either a score of 0 or 1 or a two point improvement

    Measured: At week 4, 8, 12, 16 and 20

  5. PaGA (Patients Global Assessment

    Patients evaluation on a 5-point Likert scale 1 (very good) - 5 (very poor)based on the evaluation of: "Considering all the ways your psoriasis affects you, how have you been doing in the last 24 hours?"

    Measured: At week 4,8,12,16 and 20

  6. Pruritus

    Patient evaluation of pruritus measured on a VAS (Visual Analog Scale) from 0mm (no pruritus) to 100mm (worst possible pruritus)

    Measured: At week 4, 8, 12, 16 and 20

  7. Patient rated QoL (Quality of Life)

    Patient filling in 10 questions on the DLQI QoL system with a calculated summary score and analysis of the improvement from baseline

    Measured: At week 4, 8, 12, 16 and 20

  8. Adverse events (AEs)

    Summary of incidense and severity of AEs and ADRs (Adverse Drug Reactions)/SAEs (Serious Adverse Events)/SUSARs (Suspected Unexpected Serious Adverse Reactions)

    Measured: At week 4, 8, 12, 16 and 20

  9. Safety lab test

    Summary of lab parameters and clinically relevant changes over the treatment period in standard clinical chemistry tests, standard haematology tests and urin dip stick test

    Measured: At week 20

Timeline

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

  1. First posted28 Oct 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJan 2012
  4. Study completionMay 2012

Resources

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
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01230138
Sponsor's protocol ID
FP187-201
Status last verified
Dec 2012
First submitted
24 Sep 2010
Last updated
11 Dec 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FP187 in people with Plaque Psoriasis, run by Forward-Pharma GmbH at 2 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 9 inclusion and 15 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 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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 achieving PASI 75 compared to placebo (time frame: After 20 weeks of treatment). 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 NCT01230138.

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 11 Dec 2012.

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