A Phase 3 interventional study of IBI112 and placebo /IBI112 in Psoriasis, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of IBI112 in the treatment of participants with moderate to severe plaque-type psoriasis.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 500 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 48
Drug: placebo /IBI112
Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 2 IBI112 through week 48
Drug: IBI112
Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 3 IBI112 through week 48
Drug: IBI112
IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48
placebo by subcutaneous injection cross over IBI112 by subcutaneous injection at week 16 through week 48
IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48
Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
Time frame: Week 16
Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Time frame: Week 16
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Time frame: Week 16
Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 16
PASI 100 is defined as at least a 100% reduction in PASI relative to baseline
Time frame: Week 16
Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 16
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Time frame: Week 16
Change from Baseline in Dermatology life quality index(DLQI) at week 16
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life
Time frame: Week 16
Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 52
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
Time frame: Week 52
Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 52
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Time frame: Week 52
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 52
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Time frame: Week 52
Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 52
PASI 100 is defined as at least a 100% reduction in PASI relative to baseline
Time frame: Week 52
Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 52
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Time frame: Week 52
Change from Baseline in Dermatology life quality index(DLQI) at week 52
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life
Time frame: Week 52
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Innovent Biologics (Suzhou) Co. Ltd.