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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05516979
Recruitment Status : Recruiting
First Posted : August 26, 2022
Last Update Posted : September 28, 2022
Sponsor:
Collaborator:
NBCD A/S
Information provided by (Responsible Party):
SynAct Pharma Aps

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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: 100 mg AP1189 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-center, randomized, double-blind, placebo-controlled study with 12 weeks of treatment with AP1189 or placebo
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 26, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 100 mg AP1189
Treatment period of 12 weeks given as 1 tablet daily
Drug: 100 mg AP1189
AP1189 tablets for oral use
Other Name: AP1189 tablets for oral use

Placebo Comparator: Placebo
Treatment period of 12 weeks given as 1 tablet daily
Drug: Placebo
Matching placebo for oral use




Primary Outcome Measures :
  1. Number of reported AEs [ Time Frame: 12 weeks ]
    Evaluation of the safety and tolerability of AP1189 on the number and severity of reported Adverse Events, compared with placebo

  2. Change in ACR20 [ Time Frame: 12 weeks ]
    The change in American College of Rheumatology 20% (ACR20) compared to baseline


Secondary Outcome Measures :
  1. Change in ACR50 [ Time Frame: 12 weeks ]
    The change in American College of Rheumatology 50% (ACR50) compared to baseline

  2. Change in ACR70 [ Time Frame: 12 weeks ]
    The change in American College of Rheumatology 70% (ACR70) compared to baseline

  3. Change in (CDAI) [ Time Frame: 12 weeks ]
    The change Clinical Disease Activity Index (CDAI) compared to baseline

  4. Change in DAS-28 [ Time Frame: 12 weeks ]
    The change in DAS-28, based on a CRP value, compare to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05516979


Contacts
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Contact: Thomas Jonassen, MD +45 4015 6669 tj@synactpharma.com

Locations
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Moldova, Republic of
Timofei Mosneaga Republican Clinical Hospital Recruiting
Chișinău, Moldova, Republic of
Contact: Liliana Groppa, MD         
Sponsors and Collaborators
SynAct Pharma Aps
NBCD A/S
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Responsible Party: SynAct Pharma Aps
ClinicalTrials.gov Identifier: NCT05516979    
Other Study ID Numbers: SynAct-CS007
First Posted: August 26, 2022    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases