Clinical trial NCT04704492: A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis
Official title: An Open-label, Multiple-dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Preliminary Clinical Activity and Safety of Human Mouse Chimeric Anti-CD22 Monoclonal Antibody (SM03) in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: SinoMab BioScience Ltd
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This was an open phase I trial to evaluate the PK, PD, safety,tolerability, efficacy, and immunogenicity of SM03 in patients with RA. The total study duration was approximately 16 weeks for each participant, including a screening period of maximally 4 weeks, a multiple-dose period of 2 weeks (day 0 \~ day 14), and a post-treatment follow-up period of 10 weeks (day 15 \~ day 84).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Area Under the Concentration Time Cure(AUC0-t)
timeFrame: Week 0 to 12
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Week 0,2
measure: Peak Plasma Concentration (Cmax)
timeFrame: Week 0, 2
measure: Systemic Clearance (CL)
timeFrame: Week 0 to 12
measure: Terminal Half-life (T1/2)
timeFrame: Week 0 to 12
Secondary outcomes:
measure: Number of Participants Who Experienced at Least One Adverse Event
timeFrame: Week 0 to 12
measure: Number of ACR20, ACR50, and ACR70 Responders at Week 12
timeFrame: Week 2,4,8,12
measure: Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 12
timeFrame: Week 0,2,4,8,12
Other outcomes:
measure: Number of Participants Positive for Anti-Drug Antibody (ADA)
timeFrame: Week 0,4,8,12
measure: Change From Baseline in CD19+ B-cell Count During the Study Period
timeFrame: Week 0,4,8,12
Locations:
city: Beijing
country: China
facility: Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital
Study officials:
affiliation: Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital
name: Pei Hu, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: