Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: SHR0302; Drug: SHR0302 placebo comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT02665910

SHR0302-102

Details and patient eligibility

About

Condition: Rheumatoid Arthritis Intervention: Drug: SHR0302; Drug: SHR0302 placebo comparator Phase: Phase 1 Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects who are 18~70 years of age on the day of signing informed consent,
• Have a diagnosis of RA meeting the 1987 ACR/EULAR criteria of RA and ACR functional class I-III,
• Body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 30,
• Have agreed to not use any anti- rheumatic drug except for study drugs during the study period.

Exclusion criteria

• Current therapy with any disease modifying anti-rheumatic drug (DMARD), with the exception of Methotrexate (MTX), Leflunomide, sulfasalazine, antimalarials, gold preparations, penicillamine, which must have discontinued for a period of at least 7 t1/2s prior to dosing,
• Previous RA treatment with DMARDs or drugs with strong immunosuppressive effect in 3 months prior to dosing (12 months for rituximab or other B cell depleting agents),
• Previous therapy with NSAIDs or oral glucocorticoids in 2 weeks before dosing,
• Any parenteral (intramuscular or intravenous injection) or intra-articular corticosteroids therapy in 4 weeks before dosing,
• Previous treatment with interferons in 4 weeks before dosing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

SHR0302

Experimental group

Description:

Multiple ascending doses (2, 5, 10, 25 mg), oral tablets

Treatment:

Drug: SHR0302

SHR0302 placebo comparator

Placebo Comparator group

Description:

Multiple ascending doses (2, 5, 10, 25 mg), oral tablets (matching corresponding study medication)

Treatment:

Drug: SHR0302 placebo comparator