CClinicalTrials.gg
Status unknownNCT01744327Updated May 29, 2013

TL1A Expression in Psoriatic Skin

An observational study in Psoriasis, sponsored by Bispebjerg Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-29.

Sponsored by Bispebjerg Hospital · Observational

The sponsor has not verified this record recently (last verified May 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
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Study summary

TL1A is a newly discovered signal molecule that may be crucially involved in the maintenance of chronic inflammatory disorders. TL1A has also been demonstrated in psoriatic skin but the importance of TL1A in psoriasis is still unknown. Understanding inflammatory signal molecules in psoriasis is important because the development of new drugs directed against relevant signal molecules (e.g. TNF-α and IL12/23) has proved to be a very efficacious treatment principle. However, despite the dramatic progress in therapeutic options during the last decade, there is still a fraction of patients that are insufficiently treated with the currently available therapies. TL1A has been claimed to be the next important target for development of biologics in the field of chronic inflammation.

Read the detailed description

Psoriasis is a common autoimmune disease; affecting approximately 2 % of the western population. Among these 15% are estimated to have severe disease that requires systemic therapy with e.g. methotrexate, cyclosporine or acitretin that are all drugs associated with high frequencies of side-effects. In contrast to this the recent development of the biologic drugs has provided very efficacious and in general well-tolerated new therapeutics. But even with these newer drugs treatment-failures exist and for this group new treatments are needed TNF-like ligand 1A (TL1A) is a novel member of the TNF family of cytokines. Increasing evidence suggests that in addition to TNF-alfa and IFN-gamma psoriasis is also an IL-23 and IL-17 dependent disease so TH1 and TH17 T cells are suggested to be important in driving the disease. Therefore TL1A, which through binding to DR3 influences TH1 and TH17 T cell differentiation, could be an important cytokine in the early inflammatory process in psoriasis. Recently expression of TL1A in psoriatic skin lesions has been demonstrated but the importance of this remains to be investigated.

TL1A exists in both a membrane bound- and a soluble form and is secreted from antigen presenting cells (APCs) such as monocytes, dendritic cells and macrophages in response to stimulation with immune complexes, bacteria or cytokines (TNF-alfa and IL-1beta). Membrane bound TL1A has also been described in T cells. Recently, a new isoform of soluble TL1A (TL1A(V84-L251)) was discovered with functional differences to TL1A(L72-L251. It's unknown whether this isoform is present in psoriatic skin.

Research on TL1A has focused on autoimmune diseases where immune complexes are formed, e.g. rheumatoid arthritis. However, studies have suggested that early pathogenesis in psoriasis could dependent on formation of large complexes between bacterial DNA and the anti-microbial peptide LL-37 which induce cytokine secretion from APC. Cytokines that could lead to TL1A excretion. Whether TL1A can be secreted in this way is unknown.

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Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's planned enrollment of 20 is below the median of 200 across 396 observational studies indexed under Psoriasis.

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Lead sponsor

Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Plaque type psoriasis

Inclusion criteria

  • Plaque type psoriasis
  • at least 6 month history of psoriasis

Exclusion criteria

Exclusion Criteria:

  • systemic anti-psoriatic medication
  • topical anti-psoriatic medication (wash-out period 2 weeks)
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Chronic Plaque type psoriasis

    Patients with plaque type psoriasis

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What researchers measure

Primary outcomes

  1. Expression of TL1A in psoriatic skin

    Staining intensity of TL1A by IHC in involved psoriatic skin compared to uninvolved and skin from normal controls

    Time frame: 3 months

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Study locations

1 site
  • Department of dermatology D40 , Bispebjerg Hospital
    Copenhagen, 2400 NV, Denmark
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01744327
Lead sponsor
Bispebjerg Hospital
Collaborators
AbbVie, University of Copenhagen
Responsible party
Bo Bang, MD, Ph.D (Chief Physician, Associate Professor, Bispebjerg Hospital) — Principal investigator
First posted
Dec 6, 2012
Start date
Dec 2012
Primary completion
Dec 2013 (estimated)
Last update
May 29, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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