Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
Sök Study Connect
  • NCT04947579

Active, Not Recruiting

A Study of CC-99677 in Participants With Active Ankylosing Spondylitis - CC-99677-AS-001

Uppdaterad: 9 december, 2022   |   ClinicalTrials.gov

Celgene är ett helägt dotterbolag till Bristol-Myers Squibb 

Utskriftsvänlig sammanfattning

ÄR DU INTRESSERAD AV DEN HÄR PRÖVNINGEN?
Skriv ut den här sidan och broschyren om kliniska prövningar som hjälp under samtalet med din läkare.
Använd broschyren ”Om att delta i en klinisk prövning” för att få vägledning om deltagandeprocessen i en klinisk prövning. Förstå de viktiga faktorerna som man måste tänka på före ett beslut och få hjälp med att formulera frågor till studiepersonalen.
Skriv ut den här sidan CC-99677-AS-001
Ladda ned broschyren ”Om att delta i en klinisk prövning”

VÄLJ SPRÅK

Information om prövningen

  • Phase 2

    Fas

  • Kön

  • 18-65

    Åldersintervall

  • Active, Not Recruiting

Behandlingsalternativ

Studiegrupper
TILLDELAD BEHANDLING
Experimental: Administration of CC-99677 150 mg QD PO
Drug: CC-99677
Experimental: Administration of CC-99677 150 mg QD PO.
Drug: CC-99677
Experimental: Administration of CC-99677 60mg QD PO
Drug: CC-99677
Experimental: Administration of CC-99677 60mg QD PO.
Drug: CC-99677
Placebo Comparator: Administration of Placebo QD PO
Other: Placebo
Placebo Comparator: Placebo additional dose cohort
Other: Placebo

Viktiga kriterier för deltagandet

Inclusion Criteria: - Diagnosis of Ankylosing Spondylitis (AS) fulfilling the modified New York criteria - Active axial disease at Screening and Baseline defined by a Bath Ankylosing - Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and Total Back Pain ≥ 4 - Failed prior treatment with at least 2 NSAIDs for at least 4 weeks each - Participant has never received a biologic therapy eg, tumor necrosis factor (TNF) antagonist or monoclonal antibody [mAb] against IL-17A (biologic naive main study), or have taken more than one biologic therapy (biologic-failure substudy) for the treatment of AS Exclusion Criteria: - Radiographic evidence of total ankylosis of the spine - Clinically significant back pain caused by diseases other than AS - Concurrent treatment or treatment within the 6 months prior to Baseline with cell depleting biologic agents - Participation in any study of an investigational drug, including those for COVID-19 - History of malignancy - Oral corticosteroids (prednisone or equivalent) > 10 mg/day systemically for ≥ 2 weeks prior to Baseline Visit

Vi rekommenderar att du kontaktar BMS för att rapportera biverkningar.
Biverkningar (oönskade händelser) och andra rapporterbara händelser definieras här
För att rapportera biverkningar (oönskade händelser) eller reklamera ett läkemedel: Medicinsk information

466-SE-2100058