A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp (SCALP)

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00669214
First received: April 28, 2008
Last updated: January 18, 2011
Last verified: January 2011
Results First Received: August 24, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: efalizumab
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
Efalizumab All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).

Participant Flow for 2 periods

Period 1:   Double-Blind Treatment Period (Week 12)
    Placebo     Efalizumab  
STARTED     27     62  
COMPLETED     22     55  
NOT COMPLETED     5     7  

Period 2:   Open-Label Treatment Period (Week 24)
    Placebo     Efalizumab  
STARTED     22     55  
COMPLETED     18     46  
NOT COMPLETED     4     9  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
Efalizumab All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
Total Total of all reporting groups

Baseline Measures
    Placebo     Efalizumab     Total  
Number of Participants  
[units: participants]
  27     62     89  
Age  
[units: years]
Mean ± Standard Deviation
  42.78  ± 16.53     43.16  ± 13.46     43.04  ± 14.37  
Gender  
[units: participants]
     
Female     9     30     39  
Male     18     32     50  



  Outcome Measures
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1.  Primary:   Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks   [ Time Frame: Week 12 ]

2.  Secondary:   Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks   [ Time Frame: Week 24 ]

3.  Secondary:   Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks   [ Time Frame: Week 12 ]

4.  Secondary:   Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks   [ Time Frame: Week 24 ]

5.  Secondary:   Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks   [ Time Frame: Week 12 ]

6.  Secondary:   Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks   [ Time Frame: Week 24 ]

7.  Secondary:   Mean Change in Scalpdex Score at 12 Weeks   [ Time Frame: The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84 ]

8.  Secondary:   Mean Change in Scalpdex Score at 24 Weeks   [ Time Frame: Week 24 ]

9.  Secondary:   Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks   [ Time Frame: Week 12 ]

10.  Secondary:   Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks   [ Time Frame: Week 24 ]

11.  Secondary:   Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks   [ Time Frame: Week 12 ]

12.  Secondary:   Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks   [ Time Frame: Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Since the completion of this study, efalizumab has been voluntarily withdrawn from the U.S. market because of a safety issue.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Genentech, Inc.
phone: 800-821-8590


No publications provided


Responsible Party: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00669214     History of Changes
Other Study ID Numbers: ACD4412n
Study First Received: April 28, 2008
Results First Received: August 24, 2010
Last Updated: January 18, 2011
Health Authority: United States: Institutional Review Board