Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-16

Study Completion Date

2021-02-04

Brief Summary

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This is a Phase 2 study to investigate the safety, tolerability, PK, and PD of ATI-450 plus methotrexate versus methotrexate alone in patients with moderate to severe RA.

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Detailed Description

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This is a Phase 2, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled study to investigate the safety, tolerability, PK, and PD of ATI-450 plus methotrexate versus methotrexate alone in patients with moderate to severe RA with inadequate response to methotrexate. All subjects will be required to complete a safety follow up visit 30 days post last study medication administration.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, investigator and patient-blind, sponsor-unblinded, parallel group.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The blinded placebo drug is packaged to match the active study drug and will be stored under the same conditions.

Study Groups

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ATI-450 plus Methotrexate

ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate

Group Type EXPERIMENTAL

ATI-450

Intervention Type DRUG

Oral, small molecule MK2 inhibitor

Methotrexate

Intervention Type DRUG

7.5 mg to 25 mg weekly

Placebo plus Methotrexate

Placebo oral tablet BID with a stable weekly dose of Methotrexate

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Placebo tablet manufactured to match ATI-450 in appearance

Methotrexate

Intervention Type DRUG

7.5 mg to 25 mg weekly

Interventions

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ATI-450

Oral, small molecule MK2 inhibitor

Intervention Type DRUG

Placebo oral tablet

Placebo tablet manufactured to match ATI-450 in appearance

Intervention Type DRUG

Methotrexate

7.5 mg to 25 mg weekly

Intervention Type DRUG

Other Intervention Names

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CDD-450

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
* DAS28-CRP ≥3.2 defined as moderate to high disease activity.
* Have moderately to severely active RA defined by at least 4/28 tender and 4/28 swollen joints.
* hsCRP ≥5 mg/L at screening.
* Patients must have definitive intra-articular synovitis or osteitis defined as a score of 1 or greater on a Hand-Wrist MRI as assessed by central imaging reader (using RAMRIS).
* On a stable MTX dose and a stable dose of folic or folinic acid prior to the screening visit.

Exclusion Criteria

* Patient has a current acute or chronic immunoinflammatory disease other than RA which may impact the course or assessment of RA.
* Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results.
* History or evidence of active or latent tuberculosis.
* Active infection requiring treatment with antibiotics.
* Blood pressure levels (in supine position after at least 5 minutes rest): \<90 mmHg or \>140 mmHg for systolic blood pressure or \<40 mmHg or \>90 mmHg for diastolic blood pressure.
* Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the screening visit.
* Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of the screening visit.
* Patients with history of stroke.
* Any joint procedure in the past 90 days prior to screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No