Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00382512
Other study ID # ACD2244g
Secondary ID
Status Completed
Phase Phase 1
First received September 27, 2006
Last updated September 27, 2006
Start date May 2003

Study information

Verified date September 2006
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a Phase I, randomized, placebo-controlled, single blind, parallel group, single-center study designed to evaluate immune responses during and after administration of 12 weekly SC doses of 1.0 mg/kg efalizumab in subjects with moderate plaque psoriasis.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Signed informed consent

- Plaque psoriasis covering 8%-15% of the total BSA

- Diagnosis of plaque psoriasis for at least 6 months

- Body weight of =140 kg

- 18 to 65 years old

- For women of childbearing potential and men who may father children, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study (the following methods of contraception are acceptable: condom; abstinence; oral, implantable or injectable contraceptives by the sexual partner; IUD, female condom, diaphragm with spermicide, cervical cap; a sterile sexual partner)

- Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study

- History of tetanus vaccination

Exclusion Criteria:

- Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis

- History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies or fusion proteins that contain an Ig Fc region

- Clinically significant psoriasis exacerbation during screening or at the time of enrollment

- History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection

- History of opportunistic infections (e.g., systemic fungal infections, parasites)

- Seropositivity for human immunodeficiency virus (HIV)

- Pregnancy or lactation

- White blood cell (WBC) count <4000/uL or >14,000/uL

- Seropositivity for hepatitis B or C virus

- Hepatic enzymes =3 times the upper limit of normal

- Tetanus or pneumococcal vaccination during the 6 months prior to the start of the study (Treatment Day 0) or failure to complete a primary series of tetanus immunizations

- Known hypersensitivity reaction to tetanus or diphtheria toxoid

- Known hypersensitivity to any of the administered vaccinations or their components

- History of active tuberculosis (TB) or currently undergoing treatment for TB

- Positive purified protein derivative (PPD) (tuberculin) testing at screening (as defined by CDC Guidelines, see Appendix C for test assessment criteria and listing of high-risk groups)

- Presence of malignancy within the past 5 years, including lymphoproliferative disorders

- Treatment with efalizumab (anti-CD11a) within the last 12 months

- Previous administration of <phi>X174

- Diagnosis of hepatic cirrhosis, regardless of cause or severity

- Serum creatinine =2 times the upper limit of normal

- Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year

- History of substance abuse within the last 5 years as judged by the Principal Investigator

- Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug

- Systemic therapy for psoriasis (Screening Day -28 through FU Day 98)

- Systemic immunosuppressive drugs for any indications (Screening Day -28 through FU Day 98)

- Live virus or bacteria vaccines other than protocol specified (Screening Day -14 through Treatment Day 84)

- Other vaccines or allergy desensitization (must be scheduled at least 14 days prior to Treatment Day 0 or after FU Day 98)

- Other experimental drugs or treatments (within 90 days or five half-lives, whichever is longer, prior to Treatment Day 0 and through FU Day 98)

- <beta>-Blockers, angiotensin-converting enzyme (ACE) inhibitors, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant between Screening Day -28 and Treatment Day 84)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Raptiva (efalizumab)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Mean concentrations of anti-<phi>X174 antibodies in the FU period 2 weeks after the FU Day 70 vaccinations in Group A compared with mean antibody concentrations 2 weeks after the Treatment Day 63 vaccination in Group C
Primary Mean concentrations of anti-<phi>X174 antibodies in the FU period 2 weeks after the FU Day 70 vaccination in Group B compared with mean antibody concentrations 2 weeks after the Treatment Day 63 vaccination in Group C.
Secondary Characterization of mean concentrations of anti-<phi>X174 antibodies 2 weeks after the FU Day 42 vaccination in Group A compared with mean antibody concentrations 2 weeks after the Treatment Day 35 vaccination in Group C
Secondary Characterization of mean concentrations of anti-<phi>X174 antibodies 2 weeks after the FU Day 42 vaccination in Group B compared with mean antibody concentrations 2 weeks after the Treatment Day 35 vaccination in Group C
Secondary Characterization of mean anti-<phi>X174 concentrations 2 and 4 weeks after the first and 2 and 4 weeks after the second <phi>X174 vaccinations during efalizumab treatment (Group A) compared with placebo (Group C)
Secondary Characterization of mean concentrations of anti-tetanus IgG during treatment with efalizumab compared with placebo, representing a secondary humoral immune response
Secondary Characterization of anti-pneumococcal antibody concentrations on FU Day 70 after pneumococcal vaccination on FU Day 42 compared with placebo
Secondary Percentage of subjects with positive skin test reactions to tetanus and Candida-recall antigens on FU Day 77 after washout from efalizumab compared with baseline.
See also
  Status Clinical Trial Phase
Completed NCT01194219 - Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis Phase 3
Recruiting NCT06030076 - A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
Completed NCT04263610 - Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy Phase 4
Completed NCT02601469 - Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis Phase 2
Completed NCT05600036 - A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis Phase 2
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03614078 - A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis Phase 2
Not yet recruiting NCT05036889 - A 16-week Randomized Evaluation of the Impact of Mind.Px Application on Response to Biologic Treatment in Patients Suffering From Plaque Psoriasis Through Clinical Utility and Health Outcomes. N/A
Completed NCT04603027 - A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis Phase 2
Completed NCT03638258 - The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis Phase 2
Completed NCT02881346 - Efficacy and Tolerability of Enstilar® in Daily Practice
Recruiting NCT02611349 - Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis Phase 3
Completed NCT02251678 - Evaluate the Effect of Elimune Capsules Phase 1
Completed NCT01987843 - Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 2
Terminated NCT01708629 - Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects Phase 3
Completed NCT01230138 - Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis Phase 2
Withdrawn NCT00747032 - To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis Phase 3
Completed NCT00581100 - Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis Phase 4
Suspended NCT01228656 - Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate Phase 2
Completed NCT00540618 - A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis Phase 2