---
title: IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
nct_id: NCT06049810
overall_status: COMPLETED
phase: PHASE3
sponsor: Innovent Biologics (Suzhou) Co. Ltd.
study_type: INTERVENTIONAL
primary_condition: Psoriasis
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06049810.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06049810"
ct_last_update_post_date: 2025-08-17
last_seen_at: "2026-05-12T06:54:20.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

**Official Title:** A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Randomized Withdrawal and Retreatment Phase III Clinical Trial Evaluating the Efficacy and Safety of Subcutaneous Injection of IBI112 in the Treatment of Moderate to Severe Plaque Psoriasis.

**NCT ID:** [NCT06049810](https://clinicaltrials.gov/study/NCT06049810)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 566
- **Lead Sponsor:** Innovent Biologics (Suzhou) Co. Ltd.
- **Conditions:** Psoriasis
- **Start Date:** 2023-10-10
- **Completion Date:** 2025-07-28
- **CT.gov Last Update:** 2025-08-17

## Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of IBI112 in the treatment of participants with moderate to severe psoriasis

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Have a diagnosis of plaque-type psoriasis for at least 6 months;
2. Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND static Physician's Global Assessment (sPGA) score of 3 (moderate) or greater; Psoriasis covering at least 10% of body surface area;
3. Must be a candidate for either systemic therapy or phototherapy for psoriasis.

Exclusion Criteria:

1. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
2. Participants who have ever received IBI112 or IL-23 inhibitor
3. History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
4. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the participant
5. Is pregnant, nursing, or planning a pregnancy (both men and women) within 6 months following the last administration of the study drug
```

## Arms

- **Group 3** (EXPERIMENTAL) — Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& Dose 1 IBI112 through week 44
- **Group 4** (EXPERIMENTAL) — Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 through week 44
- **Group 6** (EXPERIMENTAL) — Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& Dose 1 IBI112 through week 44
- **Group 5** (PLACEBO_COMPARATOR) — Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& placebo through week 44
- **Group 1** (EXPERIMENTAL) — Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 through week 44
- **Group 2** (PLACEBO_COMPARATOR) — Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& placebo through week 44

## Interventions

- **IBI112** (DRUG) — Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& Dose 1 IBI112 through week 44
- **IBI112/placebo** (DRUG) — Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& placebo through week 44 by subcutaneous injection
- **IBI112/placebo** (DRUG) — Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& placebo through week 44
- **IBI112** (DRUG) — Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& Dose 1 IBI112 through week 44
- **IBI112** (DRUG) — Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 through week 44
- **IBI112** (DRUG) — Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 through week 44 by subcutaneous injection

## Primary Outcomes

- **Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response** _(time frame: Week 56)_

## Secondary Outcomes

- **Percentage of participants with a PASI75 Response** _(time frame: Week 56)_
- **Percentage of participants with a PASI100 Response** _(time frame: Week 56)_
- **Percentage of participants with a static Investigator's Global Assessment (sIGA) score of 0 or 1** _(time frame: Week 56)_
- **Percentage of participants with Dermatology Life Quality Index (DLQI) Score** _(time frame: Week 56)_
- **Percentage of participants with a sIGA score of 0** _(time frame: Week 56)_
- **Cumulative Maintenance Rate of PASI 90 Response Through Week 56 to Evaluate Loss of a PASI 90 Response** _(time frame: Week 56)_
- **Changes of PASI Scores participants who relapse and retreatment** _(time frame: Week 56)_
- **Changes of sIGA score in participants who relapse and retreatment** _(time frame: Week 56)_

## Locations (1)

- Shanghai Skin Disease Hospital, Shanghai, Shanghai Municipality, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.shanghai skin disease hospital|shanghai|shanghai municipality|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06049810.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06049810*  
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