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Hidradenitis SuppurativaPhase 2NCT01516749

Anakinra as a Treatment for Hydradenitis Suppurativa

A Phase 2 study testing anakinra in people with Hidradenitis Suppurativa, run by University of California, San Francisco at 1 site in United States.

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

This is an open-label, proof-of-concept research study to assess the effectiveness of anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned intervention is to provide about 6 HS patients with anakinra 100mg daily injections to administer subcutaneously for 8 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
anakinra
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Oct 2012to Jul 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 1) Signed informed consent form with Confirmed diagnosis of hidradenitis suppurativa with moderate or severe disease activity

Who cannot join

  • Use of the following therapies:
  • Etanercept in the 4 weeks prior to the baseline visit (Day 1)
  • Adalimumab in the 8 weeks prior to the baseline visit (Day 1)
  • Infliximab in the 12 weeks prior to the baseline visit (Day 1)
  • Any other investigational biologics in the 8 weeks prior to the baseline visit (Day 1)
  • Leflunomide in the 4 weeks prior to the baseline visit (Day 1) • Thalidomide in the 4 weeks prior to the baseline visit (Day 1)
Show all 13Show fewer
  • Cyclosporine in the 4 weeks prior to the baseline visit (Day 1)
  • I.V. immunoglobulin (I.V. Ig) in the 8 weeks prior to the baseline visit (Day 1)
  • 6-Mercaptopurine, azathioprine, cyclophosphamide, or chlorambucil in the 12 weeks prior to the baseline visit (Day 1)
  • Colchicine, dapsone, mycophenolate mofetil \& systemic antibiotics in the 3 weeks prior to the baseline visit (Day 1)
  • Corticosteroids "20mg/day or >0.4 mg/kg, whichever applies, in the 1 week prior to the baseline visit (Day 1)
  • history of immunocompromise including HIV infection
  • positive Hep B surface antigen -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • San Francisco General Hospital

    San Francisco, California, 94110

Other trials in United States

About this study

Official title: An Open Label Non-randomized Study Assessing the Efficacy and Tolerability of Fixed-dose Regimen Daily Subcutaneous Anakinra for the Treatment of Moderate to Severe Hidradenitis Suppurativa

This is an open-label, proof-of-concept research study to assess the effectiveness of anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned intervention is to provide about 6 HS patients with anakinra 100mg daily injections to administer subcutaneously for 8 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for relapse of HS.

Being tested
anakinra
Keywords
hidradenitis suppurativa, anakinra
Medical subject headings
Hidradenitis Suppurativa

What participants receive

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

  • anakinraDrug

    Also called Kineret[TM]

    Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.

Study groups in NCT01516749
Study groupRoleWhat they receive
AnakinraExperimentalAll patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
Receives: Drug: anakinra

What is being measured

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

  1. Change in Modified Sartorius Score

    At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: < 5 cm, 1 point; 5-10 cm, 3 points; > 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points.

    Regional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity.

    Measured: Baseline, 8 weeks

Secondary outcomes (3)

  1. Change in Quality of Life Assessments

    The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable).

    The Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked "What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit?" with a scale of 0=no acitivity to 100=maximal activity.

    Measured: Baseline, 8 weeks

  2. Change in Dermatology Quality of Life Index (DLQI)

    Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life

    Measured: Baseline, 8 weeks

  3. Change in C-reactive Protein

    Change assessed from baseline to end of treatment phase.

    Measured: Baseline, 8 weeks

Timeline

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

  1. First posted25 Jan 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionMay 2013
  4. Study completionJul 2013

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516749
Sponsor's protocol ID
11-08101
Status last verified
Aug 2014
First submitted
7 Dec 2011
Last updated
20 Aug 2014
Data monitoring committee
No

Publications

  • Revuz JE, Canoui-Poitrine F, Wolkenstein P, Viallette C, Gabison G, Pouget F, Poli F, Faye O, Roujeau JC, Bonnelye G, Grob JJ, Bastuji-Garin S. Prevalence and factors associated with hidradenitis suppurativa: results from two case-control studies. J Am Acad Dermatol. 2008 Oct;59(4):596-601. doi: 10.1016/j.jaad.2008.06.020.

    PubMed 18674845

  • Fitzsimmons JS, Guilbert PR. A family study of hidradenitis suppurativa. J Med Genet. 1985 Oct;22(5):367-73. doi: 10.1136/jmg.22.5.367.

    PubMed 2934550

  • Stojanov S, Kastner DL. Familial autoinflammatory diseases: genetics, pathogenesis and treatment. Curr Opin Rheumatol. 2005 Sep;17(5):586-99. doi: 10.1097/bor.0000174210.78449.6b.

    PubMed 16093838

  • Steinhoff JP, Cilursu A, Falasca GF, Guzman L, Reginato AJ. A study of musculoskeletal manifestations in 12 patients with SAPHO syndrome. J Clin Rheumatol. 2002 Feb;8(1):13-22. doi: 10.1097/00124743-200202000-00005.

    PubMed 17039195

  • Rosi YL, Lowe L, Kang S. Treatment of hidradenitis suppurativa with infliximab in a patient with Crohn's disease. J Dermatolog Treat. 2005 Feb;16(1):58-61. doi: 10.1080/09546630410024547.

    PubMed 15897171

  • Hunger RE, Surovy AM, Hassan AS, Braathen LR, Yawalkar N. Toll-like receptor 2 is highly expressed in lesions of acne inversa and colocalizes with C-type lectin receptor. Br J Dermatol. 2008 Apr;158(4):691-7. doi: 10.1111/j.1365-2133.2007.08425.x. Epub 2008 Jan 30.

    PubMed 18241264

  • Sakai A, Han J, Cato AC, Akira S, Li JD. Glucocorticoids synergize with IL-1beta to induce TLR2 expression via MAP Kinase Phosphatase-1-dependent dual Inhibition of MAPK JNK and p38 in epithelial cells. BMC Mol Biol. 2004 May 4;5:2. doi: 10.1186/1471-2199-5-2.

    PubMed 15125785

  • Leslie KS, Lachmann HJ, Bruning E, McGrath JA, Bybee A, Gallimore JR, Roberts PF, Woo P, Grattan CE, Hawkins PN. Phenotype, genotype, and sustained response to anakinra in 22 patients with autoinflammatory disease associated with CIAS-1/NALP3 mutations. Arch Dermatol. 2006 Dec;142(12):1591-7. doi: 10.1001/archderm.142.12.1591.

    PubMed 17178985

  • Sartorius K, Emtestam L, Jemec GB, Lapins J. Objective scoring of hidradenitis suppurativa reflecting the role of tobacco smoking and obesity. Br J Dermatol. 2009 Oct;161(4):831-9. doi: 10.1111/j.1365-2133.2009.09198.x. Epub 2009 Apr 29.

    PubMed 19438453

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anakinra in people with Hidradenitis Suppurativa, run by University of California, San Francisco at 1 site in United States.

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 1 inclusion and 13 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 20 Aug 2014. 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 United States. 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?

Yes. Results are posted in the registry (first posted 6 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Modified Sartorius Score (time frame: Baseline, 8 weeks). 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 NCT01516749, which also lists 9 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 20 Aug 2014.

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