MABp1 IN HIDRADENITIS SUPPURATIVA REFRACTORY TO ADALIMUMAB

NCT02643654 | Completed Phase 2

• 1 other identifier: HIDRA04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder. Although adalimumab is recently licensed for moderate to severe HS, many cases fail to respond or relapse during treatment. Favorable outcomes from a recently conducted double-blind randomized clinical study on the efficacy of anakinra, one interleukin(IL)-1alpha blocker, in hidradenitis suppurativa (HS), led to validate the efficacy of MABp1, a true human antiIL-1α antibody in these cases.

Conditions

Hidradenitis Suppurativa

Keywords

interleukin-1alpha

Outcome Measures

Primary Outcomes (1)

• The efficacy of MABp1 in patients with moderate to severe HS

  This will be assessed by the difference of achievement of positive HiSCR score between the treatment group and the comparator placebo group at week 12.

  12 weeks

Secondary Outcomes (5)

• The long-term efficacy of MABp1 in patients with moderate to severe HS

  Up to 24 weeks

• The short-and long-term efficacy of MABp1 in the quality of life of patients with moderate to severe HS

  Up to 24 weeks

• The short-and long-term efficacy of MABp1 in individual lesions of patients with moderate to severe HS

  Up to 24 weeks

• The effect of MAbp1 on the time to new exacerbation

  Up to 24 weeks

• The effect of MAbp1 on the ultrasonographic findings of the skin lesions

  Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo product is manufactured following the same procedures and batch records used to manufacture the MABp1 drug product. The placebo dosage form is a sterile isotonic formulation buffer at pH 6.2-6.5. Each 10-ml Type I borosilicate glass serum vial contains 6mL of the formulation buffer, and is sealed with a 20-mm Daikyo Flurotec butyl rubber stopper and flip-off aluminum seal.

Drug: Placebo

MABp1

ACTIVE COMPARATOR

MABp1 is a recombinant human IgG1 monoclonal antibody specific for human interleukin-1α (IL-1α). The entire MABp1 heavy and light chain sequences are identical to those found in naturally-occurring human IgG1κ, with the light and heavy chain variable regions being identical to those originally expressed by a peripheral blood B lymphocyte that was obtained from a healthy individual. It is a sterile injectable liquid formulation of 50 mg/mL MABp1 in a stabilizing isotonic buffer (pH 6.4). Each 10-mL serum vial contains 6 ml of the formulation, and is sealed with a 20-mm grey bromobutyl stopper and flip-off aluminum seal

Drug: MABp1

Interventions

MABp1 DRUG

This is a sterile injectable liquid formulation of 50 mg/mL MABp1 in a stabilizing isotonic buffer (pH 6.4). Each 10-mL serum vial contains 6 ml of the formulation, and is sealed with a 20-mm grey bromobutyl stopper and flip-off aluminum seal

MABp1

Placebo DRUG

The placebo dosage form is a sterile isotonic formulation buffer at pH 6.2-6.5. Each 10-ml Type I borosilicate glass serum vial contains 6mL of the formulation buffer, and is sealed with a 20-mm Daikyo Flurotec butyl rubber stopper and flip-off aluminum seal.

Placebo

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 equal to or more than 18 years
• Diagnosis of hidradenitis suppurativa (HS)
• HS of Hurley II or III stage disease or rapidly progressive HS of Hurley I stage
• Presence of at least 3 inflamed nodules consistent with HS in the body
• At least one of the following: a) previous failure of treatment with any anti-TNF regimen; b) previous relapse under treatment with any anti-TNF regimen; c) unwillingness to receive subcutaneous adalimumab treatment
• Note: Since rapidly progressive HS of Hurley I stage as defined below is not a licensed indication for adalimumab, these patients can be enrolled irrespective or not of a history of previous adalimumab treatment.

You may not qualify if:

• History of systemic lupus erythematosus
• Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
• History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.
• 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 serious bacterial infection namely pneumonia, endocarditis, acute pyelonephritis and intrabdominal infection. These patients can be enrolled once the attending physicians confirm cure by the 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
• Pregnancy or lactation
• History of tuberculosis (latent or active). This will be excluded according to the procedure defined in the screening of patients (see below)
• Major surgery within 28 days prior to Day 0

Sponsors & Collaborators

• Evangelos J. Giamarellos-Bourboulis, M.D.: lead
• Hellenic Institute for the Study of Sepsis: collaborator

Study Sites (1)

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, 12462, Greece

Location

Related Publications (4)

• 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 BACKGROUND

• Kimball AB, Jemec GB, Yang M, Kageleiry A, Signorovitch JE, Okun MM, Gu Y, Wang K, Mulani P, Sundaram M. Assessing the validity, responsiveness and meaningfulness of the Hidradenitis Suppurativa Clinical Response (HiSCR) as the clinical endpoint for hidradenitis suppurativa treatment. Br J Dermatol. 2014 Dec;171(6):1434-42. doi: 10.1111/bjd.13270. Epub 2014 Nov 11.

  PMID: 25040429 BACKGROUND

• Kanni T, Tzanetakou V, Savva A, Kersten B, Pistiki A, van de Veerdonk FL, Netea MG, van der Meer JW, Giamarellos-Bourboulis EJ. Compartmentalized Cytokine Responses in Hidradenitis Suppurativa. PLoS One. 2015 Jun 19;10(6):e0130522. doi: 10.1371/journal.pone.0130522. eCollection 2015.

  PMID: 26091259 BACKGROUND

• Kelekis NL, Efstathopoulos E, Balanika A, Spyridopoulos TN, Pelekanou A, Kanni T, Savva A, Brountzos E, Giamarellos-Bourboulis EJ. Ultrasound aids in diagnosis and severity assessment of hidradenitis suppurativa. Br J Dermatol. 2010 Jun;162(6):1400-2. doi: 10.1111/j.1365-2133.2010.09710.x. Epub 2010 Feb 22. No abstract available.

  PMID: 20184586 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa

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

Study Officials

• Evangelos Giamarellos-Bourboulis, MD, PhD

  Hellenic Institute for the Study of Sepsis

  STUDY CHAIR

• Dimitrios Boumpas, MD, PhD

  University of Athens

  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: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: December 20, 2015
• First Posted: December 31, 2015
• Study Start: December 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: February 1, 2017
• Last Updated: March 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)