Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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. května 2017 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

  • 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

Typ studie

Intervenční

Zápis (Aktuální)

89

Fáze

  • Fáze 4

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Placebo
Lék: 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).
Experimentální: Efalizumab
Lék: 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).
Ostatní jména:
  • Raptiva

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

  1. Almost clear. Just perceptible erythema and just perceptible scaling.
  2. Mild disease. Light pink erythema with minimal scaling.
  3. Moderate disease. Dull red, clearly distinguishable erythema with diffuse scaling, some thickening.
  4. Severe disease. Deep/dark red erythema with clearly obvious and diffuse scaling and thickening.
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Genentech, Inc.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. února 2008

Primární dokončení (Aktuální)

1. ledna 2009

Dokončení studie (Aktuální)

1. ledna 2009

Termíny zápisu do studia

První předloženo

28. dubna 2008

První předloženo, které splnilo kritéria kontroly kvality

28. dubna 2008

První zveřejněno (Odhad)

30. dubna 2008

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. června 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. května 2017

Naposledy ověřeno

1. května 2017

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • ACD4412n

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit