Anakinra as a Treatment for Hydradenitis Suppurativa

NCT01516749 | Completed Phase 2 Results

• 1 other identifier: 11-08101
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. Then, the study subjects will be followed for a further 8 weeks to monitor for relapse of HS.

Conditions

Hidradenitis Suppurativa

Keywords

hidradenitis suppurativa; anakinra

Outcome Measures

Primary Outcomes (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.

  Baseline, 8 weeks

Secondary Outcomes (3)

• Change in Quality of Life Assessments

  Baseline, 8 weeks

• Change in Dermatology Quality of Life Index (DLQI)

  Baseline, 8 weeks

• Change in C-reactive Protein

  Baseline, 8 weeks

Study Arms (1)

Anakinra

EXPERIMENTAL

All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.

Drug: anakinra

Interventions

anakinra DRUG

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

Also known as: Kineret[TM]

Anakinra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• 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)
• 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 -

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (9)

• 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.

  PMID: 18674845 BACKGROUND

• 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.

  PMID: 2934550 BACKGROUND

• 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.

  PMID: 16093838 BACKGROUND

• 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.

  PMID: 17039195 BACKGROUND

• 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.

  PMID: 15897171 BACKGROUND

• 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.

  PMID: 18241264 BACKGROUND

• 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.

  PMID: 15125785 BACKGROUND

• 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.

  PMID: 17178985 BACKGROUND

• 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.

  PMID: 19438453 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

Limitations of the study include early termination leading to small numbers of subjects analyzed, and lack of control group.

Results Point of Contact

• Title: Kieron S. Leslie, MD
• Organization: University of California, San Francisco

lesliek@derm.ucsf.edu

415-206-4777

Study Officials

• Kieron S Leslie, M.D.

  University of California, San Francisco - Department of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: January 25, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 20, 2014
• Results First Posted: August 6, 2014

Record last verified: 2014-08

Locations

US (1)