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MABp1 IN HIDRADENITIS SUPPURATIVA REFRACTORY TO ADALIMUMAB

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643654
First Posted: December 31, 2015
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hellenic Institute for the Study of Sepsis
Information provided by (Responsible Party):
Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens
  Purpose
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.

Condition Intervention Phase
Hidradenitis Suppurativa Drug: MABp1 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled Clinical Trial of the Efficacy of MABp1, a- First-in-class True Human Antibody Targeting Interleukin-1alpha, in Patients With Hidradenitis Suppurativa Not Eligible for antiTNF Therapy

Resource links provided by NLM:


Further study details as provided by Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens:

Primary Outcome Measures:
  • The efficacy of MABp1 in patients with moderate to severe HS [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures:
  • The long-term efficacy of MABp1 in patients with moderate to severe HS [ Time Frame: Up to 24 weeks ]
    This will be assessed by the difference of achievement of positive HiSCR score between the treatment group and the comparator placebo group at week 24. Analysis will also be done separately for patients with previous failure or relapse under antiTNF and for patients without previous antiTNF treatment.

  • The short-and long-term efficacy of MABp1 in the quality of life of patients with moderate to severe HS [ Time Frame: Up to 24 weeks ]
    This will be assessed by the comparisons of dermatology life quality index on all study visits taking also into account the visual analogue scale. Analysis will also be done separately for patients with previous failure or relapse under antiTNF and for patients without previous antiTNF treatment.

  • The short-and long-term efficacy of MABp1 in individual lesions of patients with moderate to severe HS [ Time Frame: Up to 24 weeks ]
    This will be assessed by the comparisons of modified Sartorius score on all study visits. Analysis will also be done separately for patients with previous failure or relapse under antiTNF and for patients without previous antiTNF treatment.

  • The effect of MAbp1 on the time to new exacerbation [ Time Frame: Up to 24 weeks ]
    This will be assessed by comparing the time to new exacerbation from week 0 between the two groups of treatment. Analysis will also be done separately for patients with previous failure or relapse under antiTNF and for patients without previous antiTNF treatment.

  • The effect of MAbp1 on the ultrasonographic findings of the skin lesions [ Time Frame: Week 12 ]
    This will be assessed by comparing the changes of skin lesions at week 12 between the two groups of treatment. Analysis will also be done separately for patients with previous failure or relapse under antiTNF and for patients without previous antiTNF treatment.


Enrollment: 20
Study Start Date: December 2015
Study Completion Date: February 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
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
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.
Active Comparator: MABp1
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
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • It is explicitly stated that intake of antimicrobials for HS is not an exclusion criterion
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643654


Locations
Greece
4th Department of Internal Medicine, ATTIKON University Hospital
Athens, Greece, 12462
Sponsors and Collaborators
Evangelos J. Giamarellos-Bourboulis, M.D.
Hellenic Institute for the Study of Sepsis
Investigators
Study Chair: Evangelos Giamarellos-Bourboulis, MD, PhD Hellenic Institute for the Study of Sepsis
Principal Investigator: Dimitrios Boumpas, MD, PhD University of Athens
  More Information

Publications:
Responsible Party: Evangelos J. Giamarellos-Bourboulis, M.D., Associate Professor of Internal Medicine, University of Athens
ClinicalTrials.gov Identifier: NCT02643654     History of Changes
Other Study ID Numbers: HIDRA04
First Submitted: December 20, 2015
First Posted: December 31, 2015
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens:
interleukin-1alpha

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration