Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    anakinra, hidradenitis
Previous Study | Return to List | Next Study

Anakinra as a Treatment for Hydradenitis Suppurativa

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.
 
ClinicalTrials.gov Identifier: NCT01516749
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : August 6, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hidradenitis Suppurativa
Intervention Drug: anakinra
Enrollment 6
Recruitment Details Patients were recruited from an academic dermatology practice in San Francisco, CA; informed consent was obtained before study entry.
Pre-assignment Details 11 patients were screened for inclusion. 6 were eligible and were enrolled.
Arm/Group Title Anakinra
Hide Arm/Group Description

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

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

Period Title: Active Therapy
Started 6
Completed 5
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Period Title: Follow-up Off Therapy
Started 5
Completed 4
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Anakinra
Hide Arm/Group Description

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

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

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
Eligible per protocol criteria
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
37
(27 to 41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
4
  66.7%
Male
2
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
Initial modified Sartorius score   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 6 participants
78.5
(42 to 95)
[1]
Measure Description: The following are recorded by the dermatologist: (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 lesion if single) 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 are added and summed up to the patient’s total score. The upper limit of the scale is open.
Initial C-reactive protein   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 6 participants
30.6  (23.03)
[1]
Measure Description: Normal <3.1 mg/L
1.Primary Outcome
Title Change in Modified Sartorius Score
Hide Description

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.

Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The 5 patients who completed 8 weeks of therapy
Arm/Group Title Anakinra
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 5
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-34.8
(-62.05 to -7.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anakinra
Comments Significance of decrease in modified Sartorius score from Baseline to 8 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments significance was accepted at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Change in Quality of Life Assessments
Hide Description

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.

Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed 8 weeks of therapy
Arm/Group Title Anakinra
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 5
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Physician Global Assessment
-45.8
(-69.5 to -22.1)
Patient Global Assessment
-35.6
(-61.4 to -9.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anakinra
Comments Significance of reductions in Physican Global Assessment mean values between baseline and 8 weeks of therapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments Significance was accepted at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Anakinra
Comments Significance of reductions in Patient Global Assessment mean values between baseline and 8 weeks of therapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments Significance was accepted at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change in Dermatology Quality of Life Index (DLQI)
Hide Description 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
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed 8 weeks of therapy
Arm/Group Title Anakinra
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 5
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-8.4
(-16.57 to -0.23)
4.Secondary Outcome
Title Change in C-reactive Protein
Hide Description Change assessed from baseline to end of treatment phase.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed 8 weeks of therapy
Arm/Group Title Anakinra
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 5
Mean (95% Confidence Interval)
Unit of Measure: mg/L
-16.7
(-36.14 to 2.784)
Time Frame 16 weeks: 8 weeks of study therapy, followed by an additional 8 weeks of follow-up off therapy
Adverse Event Reporting Description Vital signs and physical examinations were undertaken at every visit. The investigators assessed adverse events throughout the study by direct patient query, observation by study personnel, and spontaneous patient reporting.
 
Arm/Group Title Anakinra
Hide Arm/Group Description

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

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

All-Cause Mortality
Anakinra
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Anakinra
Affected / at Risk (%)
Total   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anakinra
Affected / at Risk (%)
Total   6/6 (100.00%) 
Skin and subcutaneous tissue disorders   
Painful injection site  [1]  6/6 (100.00%) 
Indicates events were collected by systematic assessment
[1]
All patients reported painful injection site reactions, which decreased in severity after a few weeks of treatment.
Limitations of the study include early termination leading to small numbers of subjects analyzed, and lack of control group.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kieron S. Leslie, MD
Organization: University of California, San Francisco
Phone: 415-206-4777
EMail: lesliek@derm.ucsf.edu
Publications:
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01516749    
Other Study ID Numbers: 11-08101
First Submitted: December 7, 2011
First Posted: January 25, 2012
Results First Submitted: July 11, 2014
Results First Posted: August 6, 2014
Last Update Posted: August 20, 2014