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Plaque PsoriasisPhase 3NCT01726933

LAS41008 in Moderate to Severe Chronic Plaque Psoriasis

A Phase 3 study testing LAS41008 and LASW1835 in people with Plaque Psoriasis, run by Almirall, S.A. at 4 sites in 4 countries.

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 aim of the study is to evaluate the efficacy and safety of LAS41008 in comparison to active control and placebo in patients with moderate to severe chronic plaque psoriasis Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
LAS41008 and LASW1835
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
839 participants
Where
4 sitesin 4 countries
Study dates
Nov 2012to Nov 2015
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and personally dated written informed consent
  • Male / female
  • Aged 18 years or older
  • With a diagnosis of chronic plaque psoriasis for at least 12 months before enrollment in the study
  • With the severity of psoriasis defined as moderate to severe, as reflected in meeting all the following criteria:
  • PASI > 10
Show all 15Show fewer
  • BSA (body surface area) > 10 %
  • PGA moderate to severe
  • With general good health, or a stable medical condition not considered likely to interfere with the conduct of the clinical study, as determined by the investigator based upon results of medical history, laboratory results and physical examination
  • Prior therapy with systemic drugs for psoriasis or naïve to systemic treatment but identified as a candidate for systemic treatment.
  • With a complete record of at least 12 months of other previous topical and systemic treatments, if any
  • Adhering to the following wash-out periods Topical treatment Wash-out Period Corticosteroids Vitamin A analogues Vitamin D analogues Anthracene derivatives Tar Salicylic acid preparations 2 weeks Systemic treatment Biologics with antipsoriatic activity 3 months Conventional systemic antipsoriatic drugs and phototherapy 1 month Immunosuppressive medication (if not covered by any of the above treatments) Cytostatics 6 months Medications with known harmful influences on the kidneys 5 x halftime
  • For females of child-bearing potential: a negative serum pregnancy test at screening and willing to use highly effective methods of birth control during the study period and for 60 days after the last dose of investigational product. Additionally they must agree to have pregnancy tests while on study medication. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
  • Males (including those who have had vasectomy) must agree to use barrier contraception while on study medication
  • Willing to keep sun exposure reasonably constant and not to use tanning booths or other UV light sources for the duration of the trial

Who cannot join

  • For females: pregnant or lactating
  • With a diagnosis of guttate, erythrodermic or pustular psoriasis
  • With a hematological abnormality as follows: platelet count < 100,000/mm3, WBC count < 3,000 cells/ mm3, lymphocyte count < 1.000/µl, hemoglobin, hematocrit, or red blood cell count outside 30 % of the upper or lower limits of normal for the lab
  • With a history of malignancies except for non melanoma skin cancer
  • Suffering from significant gastrointestinal problems (ulcers, diarrhea, etc.)
  • Known to have significant renal impairment
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  • Are detected to have abnormal liver enzymes >2x the upper limit of the normal range
  • With active infectious disease
  • On systemic therapy with drugs that may interfere with the investigational products taken within the defined wash-out period
  • With a history of alcohol or drug abuse
  • Known HIV-positive status or suffering from any other immunosuppressive disease
  • Known to be hypersensitive to ingredients of the investigational products
  • Previous enrolled in this study or participating in any other drug investigational trial within the 30 days (or five half-lives whichever is longer) prior to enrolment.
  • Not willing to give consent for transmission of personal "pseudonymised" data
  • Unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Austria1 site

  • Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site

    Various

Other trials in Austria

Germany1 site

  • Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site

    Various

Other trials in Germany

Netherlands1 site

  • Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site

    Various

Other trials in Netherlands

Poland1 site

  • Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows:Almirall Investigative Site #

    Various

Other trials in Poland

About this study

Official title: A Multi-center, Randomized, Double-blind, Three-arm, 16 Week, Adaptive Phase III Clinical Study to Investigate the Efficacy and Safety of LAS41008 vs LASW1835 and vs Placebo in Patients With Moderate to Severe Chronic Plaque Psoriasis

The aim of the study is to evaluate the efficacy and safety of LAS41008 in comparison to active control and placebo in patients with moderate to severe chronic plaque psoriasis

Being tested
LAS41008, LASW1835, Placebo
Keywords
psoriasis, systemic treatment
Medical subject headings
Psoriasis

What participants receive

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

  • LAS41008Drug

    Also called Verum

    gastric resistant tablet, weekly up-titration up to maximal tolerated dosage

  • LASW1835Drug

    Also called Fumaderm initial/ Fumaderm

    gastric resistant tablet, weekly up-titration up to maximal tolerated dosage

  • PlaceboDrug

    gastric resistant tablet, weekly up-titration up to maximal tolerated dosage

Study groups in NCT01726933
Study groupRoleWhat they receive
LAS41008Experimentalup to 6 tablets/ day for 16 weeks double blind treatment period, randomized gastric resistant tablet
Receives: Drug: LAS41008
PlaceboPlacebo comparatorup to 6 tablets/ day for 16 weeks randomized, double blind gastric resistant tablet
Receives: Drug: Placebo
LASW1835Active comparatordouble blind, randomized gastric resistant tablet up to 6 tablets/ day for 16 weeks
Receives: Drug: LASW1835

What is being measured

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

  1. PASI 75

    Reduction of PASI by 75% from baseline to week 16

    Measured: 16 weeks

  2. Physician Global Assessment, PGA

    Change in PGA from baseline to week 16

    Measured: 16 weeks

Secondary outcomes (5)

  1. Body Surface Area, BSA

    Change in BSA from baseline to week 3, 8, 16 and follow up

    Measured: 16 weeks

  2. Dermatological Life Quality Index, DLQI

    Change in DLQI from baseline to week 3, 8, 16 and follow up

    Measured: 16 weeks

  3. PASI 75

    Change in PASI 75 from baseline to week 3 and 8 and follow up

    Measured: week 3 and 8

  4. PGA

    Change in PGA from baseline to week 3 and 8 and follow up

    Measured: week 3 and 8

  5. Adverse events

    Ongoing safety profile over the course of the study (treatment phase and follow up)

    Measured: ongoing

Timeline

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

  1. First posted15 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionOct 2014
  4. Study completionNov 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
839 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01726933
Sponsor's protocol ID
M41008-1102
Other IDs
2012-000055-13
Status last verified
Dec 2015
First submitted
12 Nov 2012
Last updated
2 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Warren RB, Barker JNW, Van de Kerkhof P, Reich K, Mrowietz U. Switching from a fumaric acid ester mixture to dimethylfumarate monotherapy in psoriasis. J Eur Acad Dermatol Venereol. 2019 Oct;33(10):e352-e353. doi: 10.1111/jdv.15644. Epub 2019 May 10. No abstract available.

    PubMed 31033034

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LAS41008 and LASW1835 in people with Plaque Psoriasis, run by Almirall, S.A. at 4 sites in 4 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 15 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 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Austria, Germany, Netherlands, Poland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

PASI 75 (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 NCT01726933, 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 2 Dec 2015.

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