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)
12. maj 2017 opdateret af: Genentech, Inc.
A Phase IV Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of 1.0 mg/kg Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp
This was a Phase IV randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of subcutaneous efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis with involvement of the scalp who had no previous exposure to efalizumab.
The study consisted of a screening period, a double-blind treatment period, an open-label treatment period, and an observation/follow-up period.
The study enrolled 100 patients.
11 patients were excluded from all analyses because of data issues.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
- Baselines for Raptiva group and placebo group at Day 84 are the same. The baseline is Day 0.
- Baselines for Raptiva group and placebo group at Day 168 are different. The baseline for Raptiva group at Day 168 is Day 0, but the baseline for Placebo group at Day 168 is Day 84
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
89
Fase
- Fase 4
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) documents
- Be aged 18 years or older
- Have chronic (6 months or greater) moderate to severe plaque psoriasis with involvement of the scalp
- Have a whole body Physician's Global Assessment (PGA) rating of moderate (3) or severe (4) for psoriasis
- Have a scalp surface area affected by plaque psoriasis of 30% or more, assessed using Psoriasis Scalp Severity Index (PSSI)
- Have at least one of three clinical signs involving the scalp (erythema, induration, and desquamation) be rated as at least moderate (2) with the other two rated as at least slight (1) using PSSI
- Be a candidate for systemic therapy in the opinion of the investigator
- Be naive to efalizumab treatment
- For women of childbearing potential, must be willing to use a method of contraception acceptable to the investigator to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 6 weeks after the last dose of efalizumab
Exclusion Criteria:
- Have had previous exposure to efalizumab or a history of hypersensitivity to any of its components
- Are using any excluded therapy
- Have a history of drug or alcohol abuse in the past five years
- Have a history in the past 5 years of a serious infection or currently have an ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
- Have any history of opportunistic infections (e.g., systemic fungal infections, parasites)
- Are seropositive for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)
- Have a history of active tuberculosis or are currently undergoing treatment for tuberculosis, including latent tuberculosis with isoniazid
- Have the presence or history of malignancy within the past 5 years, including lymphoproliferative disorders
- Are pregnant or breastfeeding
- Have a diagnosis of hepatic cirrhosis, regardless of cause or severity
- Have a history in the last 5 years of thrombocytopenia
- Have a history in the last 5 years of hemolytic anemia or any other clinically significant anemia
- Have been exposed to any experimental and/or unapproved drugs or treatments within 30 days or 5 half-lives, whichever is longer, before the screening visit
- Have been vaccinated with a live virus or live bacteria within the 14 days before the first dose of efalizumab
- Have any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug (efalizumab or placebo equivalent) or would significantly interfere with the patient's ability to comply with the provisions of this protocol
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
All patients received a conditioning dose of placebo equivalent 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).
|
|
Eksperimentel: 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).
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks
Tidsramme: Week 12
|
Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 12 weeks (Day 84) relative to baseline.
The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible).
The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area.
The PSSI score range was therefore 0-72.
|
Week 12
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks
Tidsramme: Week 24
|
Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 24 weeks (Day 168) relative to baseline.
The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible).
The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area.
The PSSI score range was therefore 0-72.
|
Week 24
|
|
Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks
Tidsramme: Week 12
|
Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 12 weeks (Day 84) relative to baseline.
The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible).
The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area.
The PSSI score range was therefore 0-72.
|
Week 12
|
|
Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks
Tidsramme: Week 24
|
Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 24 weeks (Day 168) relative to baseline.
The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible).
The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area.
The PSSI score range was therefore 0-72.
|
Week 24
|
|
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
Tidsramme: Week 12
|
Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 12 weeks (Day 84) Physician's Global Assessment (PGA) scale: 0: Clear. No signs of plaque psoriasis.
|
Week 12
|
|
Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks
Tidsramme: Week 24
|
Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 24 weeks (Day 168) For details on the PGA scale, refer to the Secondary Outcome Measure Description for 12 weeks.
|
Week 24
|
|
Mean Change in Scalpdex Score at 12 Weeks
Tidsramme: The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84
|
Mean change in Scalpdex score at 12 weeks (Day 84) relative to baseline.
The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.
|
The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84
|
|
Mean Change in Scalpdex Score at 24 Weeks
Tidsramme: Week 24
|
Mean change in Scalpdex score at 24 weeks (Day 168) relative to baseline.
The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.
|
Week 24
|
|
Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks
Tidsramme: Week 12
|
Mean change in VAS of patient-reported scalp itch at 12 weeks (Day 84) relative to baseline.
The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was "no itching," 5 was "moderate itching," and 10 was "severe itching."
|
Week 12
|
|
Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks
Tidsramme: Week 24
|
Mean change in VAS of patient-reported scalp itch at 24 weeks (Day 168) relative to baseline.
The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was "no itching," 5 was "moderate itching," and 10 was "severe itching."
|
Week 24
|
|
Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks
Tidsramme: Week 12
|
Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 12 weeks (Day 84) relative to baseline.
BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs).
Investigators were instructed to use the "rule of palm" to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint).
|
Week 12
|
|
Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks
Tidsramme: Week 24
|
Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 24 weeks (Day 168) relative to baseline.
BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs).
Investigators were instructed to use the "rule of palm" to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint).
|
Week 24
|
Samarbejdspartnere og efterforskere
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Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2008
Primær færdiggørelse (Faktiske)
1. januar 2009
Studieafslutning (Faktiske)
1. januar 2009
Datoer for studieregistrering
Først indsendt
28. april 2008
Først indsendt, der opfyldte QC-kriterier
28. april 2008
Først opslået (Skøn)
30. april 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juni 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. maj 2017
Sidst verificeret
1. maj 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ACD4412n
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