Anakinra in Hidradenitis Suppurativa

NCT01558375 | Completed Phase 2 DMC

• 1 other identifier: HIDRA03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Aim of this double-blind, randomized, controlled clinical trial is to compare the safety and the efficacy of anakinra over placebo for the management of patients with hidradenitis suppurativa (HS) of Hurley II and Hurley III disease stage. Patients will be evaluated on subsequent follow-up visits. Two scores will be applied: disease activity as assessed in the protocol by the investigator; and Sartorius score. Primary efficacy endpoint will be the comparisons of visual analogue scores, of disease activity, of Sartorius score and of dermatology life quality index between the two groups of treatment over follow-up.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• The efficacy of anakinra in patients with HS of Hurley II and III stage disease.

  This will be defined by the changes of scoring parameters between the two study groups over visits.

  24 weeks

Secondary Outcomes (3)

• The effect of anakinra in the ex vivo function of monocytes of patients with HS.

  24 weeks

• The effect of anakinra on the time to new exacerbation

  24 weeks

• The safety of anakinra in patients with hidradenitis suppurativa

  24 weeks

Study Arms (2)

Water for injection

PLACEBO COMPARATOR

Placebo syringes will contain 0.67ml of sterile water for injection. This will be injected daily for 12 weeks.

Drug: Water for injection

Anakinra

EXPERIMENTAL

Anakinra will be supplied in single use pre-filed glass syringes with 27-gauge needles. Anakinra syringe will contain 100mg of anakinra at a volume of 0.67 ml. This will be injected subcutaneously daily for 12 weeks.

Drug: Anakinra

Interventions

Water for injection DRUG

Placebo syringes will contain 0.67ml of sterile water for injection. This will be injecteda daily for 12 weeks.

Also known as: Sterile water

Water for injection

Anakinra DRUG

Anakinra will be supplied in single use pre-filed glass syringes with 27-gauge needles. Anakinra syringe will contain 100mg of anakinra at a volume of 0.67 ml. This will be injected subcutaneously daily for 12 weeks.

Also known as: Recombinant human IL-1 receptor antagonist

Anakinra

Eligibility Criteria

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

You may qualify if:

• written informed consent provided by the patient;
• age above 18 years;
• diagnosis of hidradenitis suppurativa; and
• disease of Hurley II or III severity stage

You may not qualify if:

• history of systemic lupus erythematosus, of rheumatoid arthritis of of seronegative inflammatory arthritis;
• any prior administration of any type of anti-TNF therapy over the last six months;
• administration of any live (attenuated) vaccine over the last 4 weeks;
• history of recurrent vein thrombosis or embolism compatible with anti-cardiolipin syndrome;
• any present or smoldering infection;
• hepatic dysfunction defined as any value of transaminases, of γ-glutamyl transpeptidase or of bilirubin\> 2 x upper normal limit;
• history of haematological or solid tumor malignancy, arterial hypertension, liver cirrhosis, HIV infection, and hepatitis virus B or C infection
• history of episodes mimicking demyelinating disorders or a definite diagnosis of multiple sclerosis
• any creatinine value above 1.5 mg/dl
• intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1mg/kg for the last three weeks;
• neutropenia defined as \<1000 neutrophils/mm3; and
• pregnancy or lactation

Sponsors & Collaborators

• University of Athens: lead

Study Sites (2)

2nd Department of Dermatology, ATTIKON University Hospital

Athens, 12462, Greece

Location

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, 12462, Greece

Location

Related Publications (5)

• Giamarellos-Bourboulis EJ, Pelekanou E, Antonopoulou A, Petropoulou H, Baziaka F, Karagianni V, Stavrianeas N, Giamarellou H. An open-label phase II study of the safety and efficacy of etanercept for the therapy of hidradenitis suppurativa. Br J Dermatol. 2008 Mar;158(3):567-72. doi: 10.1111/j.1365-2133.2007.08372.x. Epub 2007 Dec 11.

  PMID: 18076705 BACKGROUND

• Giamarellos-Bourboulis EJ, Antonopoulou A, Petropoulou C, Mouktaroudi M, Spyridaki E, Baziaka F, Pelekanou A, Giamarellou H, Stavrianeas NG. Altered innate and adaptive immune responses in patients with hidradenitis suppurativa. Br J Dermatol. 2007 Jan;156(1):51-6. doi: 10.1111/j.1365-2133.2006.07556.x.

  PMID: 17199566 BACKGROUND

• Kurzen H, Kurokawa I, Jemec GB, Emtestam L, Sellheyer K, Giamarellos-Bourboulis EJ, Nagy I, Bechara FG, Sartorius K, Lapins J, Krahl D, Altmeyer P, Revuz J, Zouboulis CC. What causes hidradenitis suppurativa? Exp Dermatol. 2008 May;17(5):455-6; discussion 457-72. doi: 10.1111/j.1600-0625.2008.00712_1.x.

  PMID: 18400064 BACKGROUND

• Pelekanou A, Kanni T, Savva A, Mouktaroudi M, Raftogiannis M, Kotsaki A, Giamarellos-Bourboulis EJ. Long-term efficacy of etanercept in hidradenitis suppurativa: results from an open-label phase II prospective trial. Exp Dermatol. 2010 Jun;19(6):538-40. doi: 10.1111/j.1600-0625.2009.00967.x. Epub 2009 Sep 16.

  PMID: 19758320 BACKGROUND

• Tzanetakou V, Kanni T, Giatrakou S, Katoulis A, Papadavid E, Netea MG, Dinarello CA, van der Meer JWM, Rigopoulos D, Giamarellos-Bourboulis EJ. Safety and Efficacy of Anakinra in Severe Hidradenitis Suppurativa: A Randomized Clinical Trial. JAMA Dermatol. 2016 Jan;152(1):52-59. doi: 10.1001/jamadermatol.2015.3903.

  PMID: 26579854 DERIVED

Related Links

• Hidradenitis suppurativa foundation

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Water; Injections; 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)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Evangelos J Giamarellos-Bourboulis, MD, PhD

  University of Athens, Medical School, Greece

  STUDY CHAIR

• Dimitrios Rigopoulos, MD, PhD

  University of Athens, Medical School, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 20, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

GR (2)