The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGColorado Blood Cancer Institute
Denver, Colorado, United States
RECRUITINGLocal Institution - 0048
New Haven, Connecticut, United States
WITHDRAWNMayo Clinic in Florida
Jacksonville, Florida, United States
Number of participants with treatment-emergent adverse events (AEs) in each indication.
Time frame: Up to 2 years after CC-97540 infusion
Number of participants with serious AEs (SAEs) in each indication.
Time frame: Up to 2 years after CC-97540 infusion
Number of participants with AEs of special interest (AESI) in each indication.
Time frame: Up to 2 years after CC-97540 infusion
Number of participants with laboratory abnormalities in each indication.
Time frame: Up to 2 years after CC-97540 infusion
Number of participants with Dose Limiting Toxicities (DLT) in each indication.
Time frame: Up to 2 years after CC-97540 infusion
Recommended Phase 2 Dose (RP2D) of CC-97540 in each indication.
Time frame: Up to 2 years after CC-97540 infusion
Proportion of participants achieving definition of remission in SLE (DORIS) remission
SLE Cohort
Time frame: At week 24
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)
SLE Cohort
Time frame: At week 24
Change in proteinuria measured by urine protein creatinine ratio (UPCR)
SLE Cohort
Time frame: At week 24
Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time frame: At week 24
Proportion of participants achieving Myositis Response Criteria (MRC) Total Improvement Score (TIS) Major Response
IIM Cohort
Time frame: At Week 24
Change in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
Only Dermatomyositis (DM) participants in the IIM Cohort
Time frame: At Week 24
Proportion of participants with ILD with no worsening of pulmonary function including forced expiratory volume (FEV1) (> 10%), forced vital capacity (FVC) (> 10%), and diffusing capacity of the lung for carbon monoxide (DLCO) (> 15%)
IIM Cohort
Time frame: At Week 24
Proportion of participants achieving a minimal clinically important difference (MCID) of 24% change from baseline of the modified Rodnan Skin Score (mRSS)
SSc Cohort
Time frame: At Week 24
Participants with an improvement from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS)
SSc Cohort
Time frame: At Week 24
The worsening of pulmonary function including FVC (>10% absolute), DLCO (>15% absolute decline) in participants with interstitial lung disease (ILD)
SSc Cohort
Time frame: At Week 24
Proportion of participants achieving low Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP)
RA cohort
Time frame: At week 24
Proportion of participants achieving simplified disease activity index (SDAI) remission
RA cohort
Time frame: At week 24
Proportion of participants with ILD with no worsening of pulmonary function including FVC (> 10%)
RA cohort
Time frame: At week 24
Maximum observed blood concentration (Cmax)
Time frame: Up to 2 years
Time of maximum observed blood concentration (Tmax)
Time frame: Up to 2 years
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))
Time frame: Up to 2 years
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University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
RECRUITINGLocal Institution - 0053
Chicago, Illinois, United States
ACTIVE_NOT_RECRUITINGLocal Institution - 0030
Baltimore, Maryland, United States
WITHDRAWNLocal Institution - 0038
Boston, Massachusetts, United States
NOT_YET_RECRUITINGLocal Institution - 0046
Boston, Massachusetts, United States
WITHDRAWNUniversity of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
NOT_YET_RECRUITING...and 44 more locations