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A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment (EXPAND)

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Phase 2
Locations
Moldova, Republic of
Study Type
Interventional
Intervention
100 mg AP1189
Placebo
Sponsored by
SynAct Pharma Aps
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  • Confirmed diagnosis of RA according to the 2010 ACR/EULAR RA classification criteria and are ACR class I-III
  • ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts).
  • Candidate for MTX treatment
  • Is about to begin treatment with MTX

  • Must meet at least one of the following parameters at Screening:

    1. positive result for anti-CCP or RF
    2. Serum CRP ≥ 6 mg/L
  • Highly active RA (CDAI > 22) at screening and baseline
  • Negative QuantiFERON-in-Tube test (QFG-IT)
  • Females of child-bearing potential must use of highly effective birth control method

Main Exclusion Criteria:

  • Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within 1 month following randomization
  • Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA. Sjögren's syndrome with RA is allowable
  • Prior history of or current inflammatory joint disease other than RA
  • Subjects with fibromyalgia
  • Use of hydroxychloroquine within 4 weeks prior the Screening Visit
  • Initiation of, or change in existing NSAID treatment within 2 weeks prior to the baseline visit
  • Corticosteroids except inhaled or nasal formulations for seasonal allergy or asthma are prohibited within 2 weeks prior to screening
  • Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
  • Have prior renal transplant, current renal dialysis, or severe renal insufficiency
  • Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
  • Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured)
  • Neuropathies or other painful conditions that might interfere with pain evaluation
  • Body weight of >150 kg
  • HBsAg positive and/or Anti-HBc with sign of current infection.

Sites / Locations

  • Timofei Mosneaga Republican Clinical HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

100 mg AP1189

Placebo

Arm Description

Treatment period of 12 weeks given as 1 tablet daily

Treatment period of 12 weeks given as 1 tablet daily

Outcomes

Primary Outcome Measures

Number of reported AEs
Evaluation of the safety and tolerability of AP1189 on the number and severity of reported Adverse Events, compared with placebo
Change in ACR20
The change in American College of Rheumatology 20% (ACR20) compared to baseline

Secondary Outcome Measures

Change in ACR50
The change in American College of Rheumatology 50% (ACR50) compared to baseline
Change in ACR70
The change in American College of Rheumatology 70% (ACR70) compared to baseline
Change in (CDAI)
The change Clinical Disease Activity Index (CDAI) compared to baseline
Change in DAS-28
The change in DAS-28, based on a CRP value, compare to baseline

Full Information

First Posted
August 24, 2022
Last Updated
September 26, 2022
Sponsor
SynAct Pharma Aps
Collaborators
NBCD A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05516979
Brief Title
A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment
Acronym
EXPAND
Official Title
A Double-blind, Multi-center, Randomized, Placebo-controlled Study of the Safety and Efficacy of 12 Weeks Extended Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients naïve to DMARD Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SynAct Pharma Aps
Collaborators
NBCD A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks daily treatment with 100 mg AP1189 in RA patients who are to start up-titration with methotrexate (MTX).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multi-center, randomized, double-blind, placebo-controlled study with 12 weeks of treatment with AP1189 or placebo
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
100 mg AP1189
Arm Type
Experimental
Arm Description
Treatment period of 12 weeks given as 1 tablet daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment period of 12 weeks given as 1 tablet daily
Intervention Type
Drug
Intervention Name(s)
100 mg AP1189
Other Intervention Name(s)
AP1189 tablets for oral use
Intervention Description
AP1189 tablets for oral use
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo for oral use
Primary Outcome Measure Information:
Title
Number of reported AEs
Description
Evaluation of the safety and tolerability of AP1189 on the number and severity of reported Adverse Events, compared with placebo
Time Frame
12 weeks
Title
Change in ACR20
Description
The change in American College of Rheumatology 20% (ACR20) compared to baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in ACR50
Description
The change in American College of Rheumatology 50% (ACR50) compared to baseline
Time Frame
12 weeks
Title
Change in ACR70
Description
The change in American College of Rheumatology 70% (ACR70) compared to baseline
Time Frame
12 weeks
Title
Change in (CDAI)
Description
The change Clinical Disease Activity Index (CDAI) compared to baseline
Time Frame
12 weeks
Title
Change in DAS-28
Description
The change in DAS-28, based on a CRP value, compare to baseline
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Confirmed diagnosis of RA according to the 2010 ACR/EULAR RA classification criteria and are ACR class I-III ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts). Candidate for MTX treatment Is about to begin treatment with MTX Must meet at least one of the following parameters at Screening: positive result for anti-CCP or RF Serum CRP ≥ 6 mg/L Highly active RA (CDAI > 22) at screening and baseline Negative QuantiFERON-in-Tube test (QFG-IT) Females of child-bearing potential must use of highly effective birth control method Main Exclusion Criteria: Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within 1 month following randomization Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA. Sjögren's syndrome with RA is allowable Prior history of or current inflammatory joint disease other than RA Subjects with fibromyalgia Use of hydroxychloroquine within 4 weeks prior the Screening Visit Initiation of, or change in existing NSAID treatment within 2 weeks prior to the baseline visit Corticosteroids except inhaled or nasal formulations for seasonal allergy or asthma are prohibited within 2 weeks prior to screening Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease Have prior renal transplant, current renal dialysis, or severe renal insufficiency Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured) Neuropathies or other painful conditions that might interfere with pain evaluation Body weight of >150 kg HBsAg positive and/or Anti-HBc with sign of current infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Jonassen, MD
Phone
+45 4015 6669
Email
tj@synactpharma.com
Facility Information:
Facility Name
Timofei Mosneaga Republican Clinical Hospital
City
Chișinău
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liliana Groppa, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment

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