A Study to Evaluate Efficacy and Safety of IBI112 in Adolescent Participants With Moderate to Severe Plaque Psoriasis

ConditionPsoriasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-18
SponsorInnovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

About this trial

The purpose of this study is to evaluate the efficacy and safety of IBI112 in the treatment of adolescent participants with moderate to severe plaque-type psoriasis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • IBI112

    Drug

    IBI112 by subcutaneous injection

  • placebo

    Drug

    placebo by subcutaneous injection

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: placeboPlacebo comparator 1 intervention
Group B: IBI112Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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.

Time frame
week 16

Secondary outcomes

1

Percentage of patients achieving PASI 50 at week 16

PASI 50 is defined as at least a 50% reduction in PASI relative to baseline

Time frame
week 16
2

Percentage of patients achieving PASI 90 at week 16

PASI 90 is defined as at least a 90% reduction in PASI relative to baseline

Time frame
week 16
3

Percentage of patients achieving PASI 100 at week 16

PASI 100 is defined as at least a 100% reduction in PASI relative to baseline

Time frame
week 16
4

Percentage of patients achieving an sPGA 0 at week 16

sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.

Time frame
week 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.