NCT04704492

Brief Summary

This was an open phase I trial to evaluate the pharmacokinetic, pharmacodynamic, safety and clinical activity profiles of anti-CD22 monoclonal antibody SM03 in patients with active RA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2013

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

1.3 years

First QC Date

January 6, 2021

Last Update Submit

January 8, 2021

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (5)

  • Area Under the Concentration Time Cure(AUC0-t)

    Pharmacokinetic endpoint: Area Under the Concentration Time Cure(AUC0-t)

    Week 0 to 12

  • Time to Maximum Plasma Concentration (Tmax)

    Pharmacokinetic endpoint: Time to Maximum Plasma Concentration (Tmax)

    Week 0,2

  • Peak Plasma Concentration (Cmax)

    Pharmacokinetic endpoint: Peak Plasma Concentration (Cmax)

    Week 0, 2

  • Systemic Clearance (CL)

    Pharmacokinetic endpoint: Systemic Clearance (CL)

    Week 0 to 12

  • Terminal Half-life (T1/2)

    Pharmacokinetic endpoint:Terminal Half-life (T1/2)

    Week 0 to 12

Secondary Outcomes (3)

  • Number of Participants Who Experienced at Least One Adverse Event

    Week 0 to 12

  • Number of ACR20, ACR50, and ACR70 Responders at Week 12

    Week 2,4,8,12

  • Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 12

    Week 0,2,4,8,12

Other Outcomes (2)

  • Number of Participants Positive for Anti-Drug Antibody (ADA)

    Week 0,4,8,12

  • Change From Baseline in CD19+ B-cell Count During the Study Period

    Week 0,4,8,12

Study Arms (1)

Biological: SM03

EXPERIMENTAL

Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0 , 2.

Drug: Biological: SM03

Interventions

Biological: SM03DRUG

Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0,2

Also known as: SM03
Biological: SM03

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
  • Moderate to severe active RA with swollen joint count (SJC) ≥ 6 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
  • At screening, either C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes.
  • Receiving methotrexate (MTX) 7.5 - 25mg/week (oral) for at least 12 weeks, at a stable dose over the past 4 weeks.

You may not qualify if:

  • Females who are pregnant, breastfeeding, or planning a pregnancy during the Treatment Period of and 12 months after the last infusion of study drug.
  • Rheumatic autoimmune disease other than RA.
  • Use of any biological DMARDs for RA within past 6 months.
  • Active infection, or history of serious or chronic infection.
  • Any significant cardiac disease, moderate to severe chronic obstructive pulmonary disease.
  • Allergy or sensitivity to components of the drug vial or any of the materials used for infusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital

Beijing, 100032, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Pei Hu, PhD,MD

    Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 11, 2021

Study Start

August 14, 2012

Primary Completion

December 16, 2013

Study Completion

December 16, 2013

Last Updated

January 11, 2021

Record last verified: 2021-01

Locations

CN(1)