A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity

March 29, 2026 updated by: Chongqing Claruvis Pharmaceutical Co., Ltd.

An Open-label, Multicenter Clinical Study on The Long-term Safety and Efficacy of Multiple Treatments With Recombinant Botulinum Toxin Type A (YY001) for Injection in Adult Upper Limb Spasticity (REHAB-2)

This is an open-label, multicenter, phase III clinical study to evaluate the long-term safety and efficacy of multiple treatments with recombinant botulinum toxin type A (YY001) for injection in adult upper limb spasticity

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Xinhua Wan
      • Chengdu, China
        • Recruiting
        • West China Hospital,Sichuan University
        • Contact:
          • Huifang Shang
      • Guangdong, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Jiehao Zhao
      • Guangzhou, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital
        • Contact:
          • Shaoling Wu
      • Hefei, China
        • Recruiting
        • The Second People's Hospital of Hefei
        • Contact:
          • Juncang Wu
      • Huai'an, China
        • Recruiting
        • Huai'an First Hospital Affiliated to Nanjing Medical University
        • Contact:
          • Yujun Qi
      • Kaifeng, China
        • Recruiting
        • The First Affiliated Hospital of Henan University
        • Contact:
          • Qingyan Qin
      • Kunming, China
        • Recruiting
        • The Second Affiliated Hospital of Kunming Medical University
        • Contact:
          • Liqing Yao
      • Shanghai, China
        • Recruiting
        • Shanghai Fudan University HuaShan Hospital
        • Contact:
          • Fang Li
      • Shanghai, China
        • Recruiting
        • Yangzhi Affiliated Rehabilitation Hospital of Tongji University
        • Contact:
          • Lingjing Jin
      • Shenzhen, China
        • Recruiting
        • Shenzhen Second People's Hospital
        • Contact:
          • Jianjun Long
      • Suzhou, China
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
          • Qi Fang
      • Taiyuan, China
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
          • pingzhi Wang
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Xiaodong Zhu
      • Xuzhou, China
        • Recruiting
        • Xuzhou Medical University Affiliated Hospital
        • Contact:
          • Jie Xiang
      • Zibo, China
        • Recruiting
        • Zibo Municipal Hospital
        • Contact:
          • Runming Sun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender.
  2. Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to enrollment) exhibiting upper limb spasticity.
  3. Subjects with Disability Assessment Scale score of at least 2 on the Principal Target of Treatment (one of four functional domains: hygiene, dressing, limb position and pain).

Exclusion Criteria:

  1. History of allergy to any component of the experimental drugs.
  2. Previous use of any botulinum toxin within 6 months prior to enrollment, or plan to use other botulinum toxins not specified in the study protocol during the study.
  3. Fixed contractures of the studied limb.
  4. Any medical condition that may increase the risk to the subject when using botulinum toxin type A.
  5. Need for treatment with drugs that interfere with neuromuscular function during the study.
  6. Plan or anticipate to use new antispasticity drugs during the study.
  7. History of epilepsy.
  8. Pregnant or breastfeeding women.
  9. Participation in other drug/device clinical trials within 1 month prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recombinant botulinum toxin type A (YY001)
Multiple injection with recombinant botulinum toxin type A for injection (YY001) in upper limb spasticity
Biological: Recombinant botulinum toxin type A for injection (YY001)
Prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose for single treatment is 200 to 400 U.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events and Serious Adverse Events
Time Frame: Up to 48 weeks
Up to 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician's Global Assessment (PGA) Score
Time Frame: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
The Physician's Global Assessment is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point scale that ranges from -3 = very much worse to +3 = very much improved.
Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
Change From Baseline in MAS Score of Primary Target Clinical Pattern
Time Frame: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment

Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed elbow or flexed wrist or clenched fist.

The Modified Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 6-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
Response Rates on MAS Calculated for the Primary Target Clinical Pattern
Time Frame: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment

Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed elbow or flexed wrist or clenched fist.

Subjects with a MAS reduction of one point were defined as responder.
Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
The Proportion with Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain Score Reduction of ≥1 Point
Time Frame: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
The DAS consists of the four domains hygiene, dressing, limb position and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
Incidence of Anti-drug Antibodies and Neutralizing Antibodies
Time Frame: Up to 48 weeks
Up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Claruvis Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YY001-002-CN02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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