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PsoriasisPhase 2NCT02209753

BIRB 796 BS Versus Placebo in Patients With Moderate to Severs Plaque-type Psoriasis

A Phase 2 study testing BIRB 796 BS, low dose, BIRB 796 BS, medium dose 1 and BIRB 796 BS, medium dose 2 in people with Psoriasis, run by Boehringer Ingelheim.

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 clinical objective of this study was to determine the effect of BIRB 796 BS on pharmacodynamic markers of psoriasis as a measure of efficacy, to determine the population pharmacokinetics of BIRB 796 BS and to determine the safety of BIRB 796 BS over 4 weeks of treatment in patients with moderate to severe… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psoriasis
What is being tested?
BIRB 796 BS, low dose, BIRB 796 BS, medium dose 1 and BIRB 796 BS, medium dose 2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
182 participants
Where
No sites listed yet
Study dates
Jun 2001to Sep 2002
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with stable moderate to severe plaque-type psoriasis involving ≥5% body surface area
  • History of plaque psoriasis for a minimum of 6 months prior to screening
  • Age 18 - 75
  • Males or females, females must be of non-childbearing potential (6 months post-menopausal, surgically sterilized) or using an approved form of birth control (oral contraceptives, Norplant®, Depo-Provera®, intrauterine device (IUD), double-barrier) and have a negative serum pregnancy test upon screening (Visit 1) and a negative urine test prior to randomization (Visit 2) into the trial
  • Give informed consent and sign an approved consent form prior to any study procedures, including washout of prohibited medications

Who cannot join

  • Primary guttate, erythrodermic, or pustular psoriasis
  • Psoriasis which has failed to improve significantly with systemic treatments such as cyclosporine or methotrexate. Patients resistant to one, but have had a documented response to another may be included with approval of the medical monitor. Treatment failure will not include failure to improve if a full course of treatment was unable to be completed due to adverse events, intolerance of the treatment or administrative reasons
  • Patients who have experienced treatment failure with a TNF-blocking agent. Treatment failure is defined as not achieving at least a 40% reduction in PASI score or having the TNF-blocking agent discontinued due to lack of efficacy
  • Patients unable to wash out of all current psoriasis treatments (systemic, topical and phototherapy) except emollients and shampoos prior to beginning trial medication
  • Patients taking the following medications known to elevate liver enzymes who have not been taking these medications at a stable dose for at least 1 month (3 months for diclofenac) without changes to liver functions tests (LFTs) prior to randomization (Visit 2): estrogens, oral contraceptives, selective serotonin reuptake inhibitors (SSRIs), nonsteroidal anti-inflammatory drugs (NSAIDs), acetominophen ≤3 g/day, aspirin, vitamin supplements (at recommended daily allowance doses). Patients taking doses of acetaminophen greater than three grams per day are excluded. Any other medication known to elevate hepatic enzymes not listed above is excluded
  • Patients using any of the medications listed in the protocol, without the appropriate washout period
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  • Patients with clinically significant abnormal baseline hematology, blood chemistry or urinalysis if the abnormality defines a disease listed as an exclusion criterion. All patients with a serum glutamate oxaloacetate transaminase, serum glutamate pyruvate transaminase , alkaline phosphatase greater than 1.5 x upper limit of normal (ULN) or total bilirubin greater than 1.0 x ULN will be excluded regardless of the clinical condition. Patients with serum creatinine, white blood cell (WBC) count, amylase, lipase, prothrombin time (PT), partial thromboplastin time (PTT), D-dimer, fibrin degradation product (FDP) greater than 1.5 x ULN, or blood smear poikilocytes or schistocytes greater than 1.0 x ULN will also be excluded. Patients with hemoglobinuria or proteinuria greater than 1+ will be excluded. Hemoglobinuria must be confirmed as hematuria with finding of red blood cell (RBC) on microscopic examination. Hematuria in a menstruating female will not require exclusion but must be repeated after menses has cleared prior to entry. Repeat laboratory testing is allowed once at screening prior to excluding the patient, to avoid excluding patients with transient or erroneous abnormal laboratory values
  • Any clinically significant psychiatric illness which may interfere with the patient's participation in the trial or ability to interpret the trial results
  • History of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
  • Patients with any history of heart failure, patients with a recent history (i.e., 1 year or less) of myocardial infarction or patients with any arrhythmia requiring drug therapy
  • Any ECG value outside of the reference range of clinical relevance including, but not limited to, QTcB >480 ms, PR interval >240 ms, QRS interval >110 ms
  • History of malignancy in the past 5 years except treated cutaneous squamous cell or basal cell carcinoma
  • Any active immunodeficiency or active infection, or any serious infection (requiring hospitalization or IV/intramuscular antibiotics) in the past 3 months prior to screening. Patients testing positive to human immunodeficiency virus (HIV), hepatitis B or hepatitis C will be excluded
  • History of prior tuberculosis infection or active tuberculosis, patients must have a negative skin test or chest x-ray within the past 6 months prior to screening (Visit 1)
  • History of drug or alcohol abuse within the past 2 years, active drug or alcohol abuse, or patients who consume more than three alcoholic drinks per day
  • Patients who have taken an investigational drug within one month (30 days) or six half lives (whichever is greater) prior to screening (Visit 1). Patients who have been treated with any investigational antibody or other biological agent within the past 3 months are excluded

About this study

Official title: Phase II, Randomized, Double-blind, Placebo Controlled, Multi-center, Four Week Trial of BIRB 796 BS 5, 10, 20 and 30 mg Oral Tablets Versus Placebo Administered BID in Patients With Moderate to Severe Plaque-type Psoriasis

The clinical objective of this study was to determine the effect of BIRB 796 BS on pharmacodynamic markers of psoriasis as a measure of efficacy, to determine the population pharmacokinetics of BIRB 796 BS and to determine the safety of BIRB 796 BS over 4 weeks of treatment in patients with moderate to severe plaque-type psoriasis.

Conditions
Psoriasis
Being tested
BIRB 796 BS, low dose, BIRB 796 BS, medium dose 1, BIRB 796 BS, medium dose 2, BIRB 796 BS, high dose, Placebo
Medical subject headings
Psoriasis

What participants receive

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

  • BIRB 796 BS, low doseDrug

  • BIRB 796 BS, medium dose 1Drug

  • BIRB 796 BS, medium dose 2Drug

  • BIRB 796 BS, high doseDrug

  • PlaceboDrug

Study groups in NCT02209753
Study groupRoleWhat they receive
BIRB 796 BS, low doseExperimentalNot described
Receives: Drug: BIRB 796 BS, low dose
BIRB 796 BS, medium dose 1ExperimentalNot described
Receives: Drug: BIRB 796 BS, medium dose 1
BIRB 796 BS, medium dose 2ExperimentalNot described
Receives: Drug: BIRB 796 BS, medium dose 2
BIRB 796 BS, high doseExperimentalNot described
Receives: Drug: BIRB 796 BS, high dose
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Change from baseline for the total Psoriasis Area and Severity Index (PASI) score

    Measured: after 4 weeks of treatment

  2. Percent change from baseline for pathological thickness

    Measured: after 4 weeks of treatment

  3. Percentage of K16 negative assessments

    Measured: at week 4

  4. Number of patients with adverse events

    Measured: up to 120 days

  5. Number of patients with clinically significant effects on laboratory values

    Measured: up to 36 days

  6. Number of patients with abnormal findings in electrocardiogram

    Measured: up to day 29

  7. Number of patients with clinically significant changes in vital signs

    Measured: up to day 36

Secondary outcomes (19)

  1. Absolute change from baseline in the number of epidermal T cells

    Measured: after 4 weeks of treatment

  2. Absolute change from baseline in the number of dermal T cells

    Measured: after 4 weeks of treatment

  3. Relative (%) change from baseline in the number of dermal T cells

    Measured: after 4 weeks of treatment

  4. Relative (%) change from baseline in the number of epidermal T cells

    Measured: after 4 weeks of treatment

  5. PASI 50 responder

    reduction of total PASI score by 50% or more

    Measured: after 4 weeks of treatment

  6. Assessment of target lesions on a 5-point numeric scale

    Measured: day 1 and 29

  7. Quantitative reverse transcriptase polymerase chain reaction (RT-PCR) gene expression for cytokines

    Measured: days 1, 8 and 29

  8. Reduction of serum immunological markers of disease activity

    Measured: day 1 and 29

  9. Change in score of total body lesion

    Measured: day 1 and 29

  10. Reduction of inducible nitric oxide synthase (iNOS)

    Measured: day 1 and 29

  11. PASI 75 responder

    reduction of total PASI by 75%

    Measured: after 4 weeks of treatment

  12. Histopathological global assessment on a 4-point scale

    Measured: after 4 weeks of treatment

  13. Keratin K16 improvement score

    Measured: after 4 weeks of treatment

  14. 20% reduction responder variable for pathological thickness

    Measured: after 4 weeks of treatment

  15. 20% reduction responder variable for iNOS

    Measured: after 4 weeks of treatment

  16. Reduction of K16 mRNA

    Measured: day 1 and 29

  17. Reduction of COX-2 mRNA

    Measured: day 1 and 29

  18. 20% reduction responder variable for K16

    Measured: after 4 weeks of treatment

  19. 20% reduction responder variable for interleukin 8 mRNA

    Measured: after 4 weeks of treatment

Timeline

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

  1. First posted6 Aug 2014 (estimated)
  2. Study startJun 2001
  3. Primary completionSep 2002

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
Double blind
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02209753
Sponsor's protocol ID
1175.10
Status last verified
Aug 2014
First submitted
5 Aug 2014
Last updated
6 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIRB 796 BS, low dose, BIRB 796 BS, medium dose 1 and BIRB 796 BS, medium dose 2 in people with Psoriasis, run by Boehringer Ingelheim.

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 5 inclusion and 16 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 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

Change from baseline for the total Psoriasis Area and Severity Index (PASI) score (time frame: after 4 weeks of treatment). The study lists 7 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 NCT02209753.

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 6 Aug 2014.

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