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PsoriasisPhase 2PSARTROSNCT02483234

Psoriasis-Arthritis & Bone Program

A Phase 2 study testing secukinumab in people with Psoriasis and Psoriatic Arthritis, run by University of Erlangen-Nürnberg Medical School at 1 site 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

Purpose and rationale: To define the role of IL-17 as a mediator of structural bone lesions in psoriasis patients and patients with PsA. Primary Objective is the improvement of the PsAMRIS synovitis score baseline vs. week 24. Drug tested is Secukinumab 300 mg administered weekly for 4 weeks, then 4 weekly s.c. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis, Psoriatic Arthritis
What is being tested?
secukinumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteGermany
Study dates
31 May 2015to 30 Sep 2018
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients eligible for inclusion in this study have to fulfill all of the following criteria:
  • Subjects taking DMARDs (e.g. MTX) are allowed to continue their medication if the dose is stable for at least 4 weeks before baseline and should remain on a stable dose up to Week 24.
  • Subjects who have previously been treated with TNFα inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization
  • PsA patients:
  • Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
  • Rheumatoid factor and anti-CCP antibodies negative at screening
Show all 12Show fewer
  • Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs
  • Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before baseline and should remain on a stable dose up to Week 24
  • Psoriasis patients:
  • moderate-to severe psoriasis (PASI > 6)
  • no diagnosis of PsA
  • inflammatory and/or structural lesions and/or erosions in the MRI/HR-qCT scan

Who cannot join

  • • Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
  • Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
  • Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
  • Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at baseline. The following wash out periods need to be observed:
  • Oral or topical retinoids 4 weeks
  • Photochemotherapy (e.g. PUVA) 4 weeks
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  • Phototherapy (UVA or UVB) 2 weeks
  • Topical skin treatments (except in face, scalp and genital area during screening, only corticosteroids with mild to moderate potency) 2 weeks
  • Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα or IL-23p40, investigational or approved
  • Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for a minimum of 20 weeks after stopping treatment. Effective contraception is defined as either:
  • Barrier method: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicide (where available). Spermicides alone are not a barrier method of contraception and should not be used alone
  • The following methods are considered more effective than the barrier method and are also acceptable:
  • Total abstinence: When this is in line with the preferred and usual lifestyle of the subject [Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]
  • Female sterilization: have had a surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
  • Use of established oral, injected or implanted hormonal methods of contraception, intrauterine device (IUD) or intrauterine system (IUS). In case of use of oral contraception women should have been stabile on the same pill for a minimum of 12 weeks before taking study treatment.
  • Active ongoing inflammatory diseases other than PsA that might confound the evaluation of the benefit of secukinumab therapy
  • Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the subject and/or places the subject at unacceptable risk for participation in an immunomodulatory therapy
  • History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST), SGPT (ALT), alkaline phosphatase, or serum bilirubin. The investigator should be guided by the following criteria:
  • Any single parameter may not exceed 2 x upper limit of normal (ULN). A single parameter elevated up to and including 2 x ULN should be re-checked once more as soon as possible, and in all cases, at least prior to enrollment/randomization, to rule out lab error
  • If the total bilirubin concentration is increased above 2 x ULN, total bilirubin should be differentiated into the direct and indirect reacting bilirubin. In any case, serum bilirubin should not exceed the value of 1.6 mg/dL (27 µmol/L)
  • Screening total WBC count <3,000/µL, or platelets <100,000/µL or neutrophils <1,500/µL or hemoglobin <8.5 g/dL (85g/L)
  • Active systemic infections during the last two weeks (exception: common cold) prior to randomization
  • History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by either a positive PPD skin test (the size of induration will be measured after 48-72 hours, and a positive result is defined as an induration of ≥ 5mm or according to local practice/guidelines) or a positive QuantiFERON TB-Gold test as indicated in the assessment schedule Table 1: Assessment Schedule (Screening to week 24) . Subjects with a positive test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established then treatment according to local country guidelines must have been initiated.
  • Known infection with HIV, hepatitis B or hepatitis C at screening or randomization
  • History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)
  • History or evidence of ongoing alcohol or drug abuse, within the last six months before randomization
  • Plans for administration of live vaccines during the study period or within 6 weeks preceding randomization.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University of Erlangen-Nuremberg

    Erlangen, 91054

Other trials in Germany

About this study

Official title: Evaluation of Inflammatory and Structural Joint Damage in Patients With Psoriasis and Psoriatic Arthritis Treated With Secukinumab: A Phase 2, Single Arm, Single Centre Mode of Action Study (Psoriasis-Arthritis & Bone Program, PSARTROS)

Purpose and rationale: To define the role of IL-17 as a mediator of structural bone lesions in psoriasis patients and patients with PsA. Primary Objective is the improvement of the PsAMRIS synovitis score baseline vs. week 24.

Drug tested is Secukinumab 300 mg administered weekly for 4 weeks, then 4 weekly s.c. with a duration total of 24 weeks. Indication for this study is Psoriasis (Pso) and psoriatic arthritis (PsA).

Being tested
secukinumab
Medical subject headings
Psoriasis, Arthritis, Psoriatic

What participants receive

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

  • secukinumabDrug

Study groups in NCT02483234
Study groupRoleWhat they receive
Psoriasis/Psoriatic arthritisExperimentalPatients with Psoriasis and inflammatory and/or structural lesions and/or erosions in the MRI/HR-qCT scan will be treated with Secukinumab. Patients with psoriatic arthritis will be treated with Secukinumab. Bone changes will be evaluated influenced by IL-17 blockade
Receives: Drug: secukinumab

What is being measured

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

  1. The improvement of the PsAMRIS synovitis score

    Measured: baseline to week 24

Timeline

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

  1. First posted26 Jun 2015 (estimated)
  2. Study start31 May 2015
  3. Primary completion30 Jun 2018
  4. Study completion30 Sep 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02483234
Sponsor's protocol ID
CAIN457F2301T
Acronym
PSARTROS
Status last verified
Sep 2019
First submitted
24 Jun 2015
Last updated
27 Sep 2019
Results posted
No
Data monitoring committee
No

Publications

  • Kampylafka E, Tascilar K, Lerchen V, Linz C, Sokolova M, Zekovic A, Kleyer A, Simon D, Rech J, Sticherling M, Schett G, Hueber AJ. Secukinumab leads to shifts from stage-based towards response-based disease clusters-comparative data from very early and established psoriatic arthritis. Arthritis Res Ther. 2020 Sep 9;22(1):207. doi: 10.1186/s13075-020-02268-y.

    PubMed 32907626

  • Kampylafka E, Simon D, d'Oliveira I, Linz C, Lerchen V, Englbrecht M, Rech J, Kleyer A, Sticherling M, Schett G, Hueber AJ. Disease interception with interleukin-17 inhibition in high-risk psoriasis patients with subclinical joint inflammation-data from the prospective IVEPSA study. Arthritis Res Ther. 2019 Jul 26;21(1):178. doi: 10.1186/s13075-019-1957-0.

    PubMed 31349876

  • Kampylafka E, d'Oliveira I, Linz C, Lerchen V, Stemmler F, Simon D, Englbrecht M, Sticherling M, Rech J, Kleyer A, Schett G, Hueber AJ. Resolution of synovitis and arrest of catabolic and anabolic bone changes in patients with psoriatic arthritis by IL-17A blockade with secukinumab: results from the prospective PSARTROS study. Arthritis Res Ther. 2018 Jul 27;20(1):153. doi: 10.1186/s13075-018-1653-5.

    PubMed 30053825

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing secukinumab in people with Psoriasis and Psoriatic Arthritis, run by University of Erlangen-Nürnberg Medical School at 1 site 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 12 inclusion and 28 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 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

The improvement of the PsAMRIS synovitis score (time frame: baseline to week 24). 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 NCT02483234, which also lists 3 linked publications.

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 27 Sep 2019.

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