Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03368235
• Date of registration: 03/11/2017
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis
• Scientific title: A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 Compared to Prednisolone 20 mg in Patients With Active Rheumatoid Arthritis (RA)
• Date of first enrolment: January 18, 2018
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03368235
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Denmark, Netherlands, Sweden

Contacts

• Name: Jacob M Van Laar, Professor
• Affiliation: UMC Utrecht

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Established RA diagnosis according to the 2010 American College of Rheumatology
(ACR)/EULAR classification or the 1987 criteria

2. Active RA (DAS28-CRP score = 3.2) with at least 3 swollen joints and 3 tender joints
using the DAS28 joint count

3. Patients must have be on stable dosing of conventional and/or s.c./i.v biological
DMARDs for the last 8 weeks prior to Visit 1

4. CRP levels >5mg/L at screening if seronegative for Rheumatoid Factor (RF) and
Anti-Cyclic Citrullinated Peptide antibody (anti-CCP Ab), or >2mg/L if seropositive
for either marker

5. BMI between 18 and 35 (inclusive)

6. Negative pregnancy test (serum) for female subjects of childbearing potential

Exclusion Criteria:

1. History or current inflammatory rheumatic disease other than RA (secondary Sjogren's
syndrome excluded)

2. History or current clinically important disease which may either put the subject at
risk because of participation in the study, or influence the results or the subject's
ability to participate in the study

3. Any clinical contraindications to treatment with steroids

4. Oral or parenteral steroids (beyond study medication) 8 weeks prior to study start and
during the study. Stable use and dose of topical and inhaled steroids for longer than
4 w prior to randomization is acceptable

5. Use of any prohibited medication during the study or if the required washout time of
such medication was not adhered to

6. History of severe allergy/hypersensitivity or ongoing clinically important
allergy/hypersensitivity to drugs with a similar class to study drugs

7. Any concomitant medications that are known to be associated with Torsades de Pointes



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Prednisolone

Drug: AZD9567

Primary Outcome(s)

Least Square (LS) Mean Change From Baseline in 28 Joint Disease Activity Score Using C-Reactive Protein (DAS28-CRP) at Day 15 [Time Frame: Baseline (Day 1) and Day 15]

Secondary Outcome(s)

Area Under the Plasma Concentration-Time Curve Until the Last Quantifiable Concentration (AUClast) of AZD9567 [Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15.]

LS Mean Change From Baseline in TJC28 Score at Day 15 [Time Frame: Baseline and Day 15]

LS Mean Change From Baseline in SJC28 Score at Day 15 [Time Frame: Baseline and Day 15]

Maximum Observed Plasma Concentration (Cmax) of AZD9567 [Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15.]

Area Under the Concentration-Time Curve From Time Zero to 6 Hours After Dose (AUC0-6) of AZD9567 [Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15.]

LS Mean Change From Baseline in TJC68 Score at Day 15 [Time Frame: Baseline and Day 15]

LS Mean Change From Baseline in Participant's Assessment of Pain Score at Day 15 [Time Frame: Baseline and Day 15]

Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Responses [Time Frame: Day 15]

LS Mean Change From Baseline in CRP at Day 15 [Time Frame: Baseline and Day 15]

LS Mean Change From Baseline in Participant's Assessment of Physical Function Score at Day 15 [Time Frame: Baseline and Day 15]

LS Mean Change From Baseline in Physician's Global Assessment of Disease Activity Score at Day 15 [Time Frame: Baseline and Day 15]

Time to Reach Maximum Plasma Concentration (Tmax) of AZD9567 [Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15.]

LS Mean Change From Baseline in SJC66 Score at Day 15 [Time Frame: Baseline and Day 15]

Last Plasma Concentration Measured Before the Last Dose (Ctrough) of AZD9567 [Time Frame: Predose on Day 15]

LS Mean Change From Baseline in GH Score at Day 15 [Time Frame: Baseline and Day 15]

Secondary ID(s)

D6470C00003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03368235