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A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease (SynAct-CS002)

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ClinicalTrials.gov Identifier: NCT04004429
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
SynAct Pharma Aps

Brief Summary:
This is a multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with repeated doses of AP1189. The study population will consist of newly diagnosed subjects with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) > 22, who are to start up-titration with methotrexate.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: 50 mg AP1189 Drug: AP1189 Drug: Placebo Phase 2

Detailed Description:

A multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with repeated doses of AP1189. The study population will consist of newly diagnosed subjects with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) > 22, who are to start up-titration with methotrexate.

The study will be conducted in two parts separated by an interim analysis.

Part 1: The subjects will be randomized in a 1:1:1 ratio into: .

  • AP1189 dose 50 mg
  • AP1189 dose 100 mg
  • placebo

INTERIM ANALYSIS

Part 2: All subjects will be randomized into either design 1, 2 or 3 based on data from the interim analysis.

  • Design 1: AP1189 dose 50 mg or placebo in a 2:1 ratio
  • Design 2: AP1189 dose 100 mg or placebo in a 2:1 ratio
  • Design 3: Continue with the same doses as in Part 1

The purpose of this study is to determine the safety and efficacy of 2 doses of AP1189 compared with placebo after 4 weeks of treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, two-part, randomized, double-blind, placebo-controlled 4-week study with repeated doses of AP1189
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Multicenter, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients With Active Joint Disease
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 50 mg AP1189
50 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
Drug: 50 mg AP1189
50 mg AP1189 powder in bottle
Other Name: AP1189

Experimental: 100 mg AP1189
100 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
Drug: AP1189
100 mg AP1189 powder in bottle

Placebo Comparator: Placebo
Placebo. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension i e. the powder will be added 50 ml water.
Drug: Placebo
Placebo powder in bottle




Primary Outcome Measures :
  1. Change in CDAI [ Time Frame: 4 weeks ]
    The change in CDAI score from severe (CDAI > 22) to moderate (CDAI <= 22) after 4 weeks treatment compared to baseline.


Secondary Outcome Measures :
  1. Swollen and tender joints [ Time Frame: 4 weeks ]
    Proportion of subjects achieving a reduction of more than 10 swollen and/or tender joints compared to baseline

  2. CDAI score [ Time Frame: 4 weeks ]
    Proportion of subjects achieving a change in CDAI score compared to baseline

  3. DAS28 score [ Time Frame: 4 weeks ]
    Proportion of subjects achieving a change in DAS28 compared to baseline

  4. HAQ-DI (Health Assessment Questionnaire-Disability Index) questionnaire [ Time Frame: 4 weeks ]
    Proportion of subjects achieving a change in HAQ-DI

  5. FACIT-Fatigue questionnaire [ Time Frame: 4 weeks ]
    Proportion of subjects achieving a change in FACIT-Fatigue

  6. ACR (American College of Rheumatology) response [ Time Frame: 4 weeks ]
    Proportion of subjects achieving a response assessed by ACR20, ACR50 and ACR70


Other Outcome Measures:
  1. Effect of AP1189 as measured on the following biomarkers: CXCL13, IL-1β, IL-6, IL-10, and TNF-α [ Time Frame: 4 weeks ]
    Effect of AP1189, compared to placebo and by treatment group on inflammatory and collagen destructive biomarkers



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

Inclusion Criteria:

  • Written informed consent has been obtained prior to initiating any study specific procedures
  • Male and female subjects, 18 to 85 years of age
  • Confirmed diagnosis of (RA) Rheumatoid Arthritis according to the 2010 ACR/EULAR RA classification criteria
  • Polyarthritis with joint swelling and tenderness of a minimum of three joints out of 68 joints tested
  • Candidate for Methotrexate treatment
  • Is about to begin treatment with MTX (Methotrexate)
  • Tested positive for anti-CCP Anti-cyclic citrullinated peptide) or RF (Rheumatoid Factor)
  • Severe active RA (CDAI > 22) at screening and baseline
  • Negative QFG-IT (QuantiFERON-in-Tube test)
  • Subjects should be able to complete the PRO (Patient Reported Outcome) questionnaires
  • Females of child-bearing potential may only participate if using reliable means of contraception or are post-menopausal. Surgically sterilized women at least 6 months prior to screening
  • Females of childbearing potential must have a negative pregnancy test at screening and baseline

Exclusion Criteria:

  • Participation in any other study involving investigational drug(s) within 4 weeks prior to study entry
  • Major surgery within 8 weeks prior to screening or planned surgery within 1 month following randomization
  • Rheumatic autoimmune disease other than RA, including SLE (systemic Lupus Erythematosus), MCTD (Mixed Connective Tissue Disease), scleroderma, polymyositis, or significant systemic involvement secondary to RA. Sjögren syndrome with RA is allowable
  • Functional class IV as defined by the ACR Criteria for Classification of Functional Status in RA or wheelchair/bedbound
  • Prior history of or current inflammatory joint disease other than RA
  • Subjects with fibromyalgia
  • Initiation or change in dose for NSAIDs within 2 weeks prior to dosing with the IMP (Investigational Medicinal Product)
  • Corticosteroids are prohibited within 2 weeks prior to screening (and during the entire treatment period and until the final visit
  • 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 (determined by a derived glomerular filtration rate (GFR) using Cockcroft Gault Formula of ≤30 mL/min/1,73 m2 calculated by the local lab)
  • 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
  • Pregnant women or nursing mothers
  • History of alcohol, drug, or chemical abuse within the 6 months prior to screening
  • Neuropathies or other painful conditions that might interfere with pain evaluation
  • Body weight of >150 kg

Exclusion criteria that only applies for Norway

  • Evidence of moderate and/or severe organ dysfunction
  • Abnormal chest x-ray (as per the discretion of the investigator
  • Evidence of positive hepatitis serology
  • Evidence of peptic ulcer disease

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): NCT04004429


Contacts
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Contact: Irene Sandholdt +45 2015 7033 isa@croxxmed.com
Contact: Birgitte Telmer, MD +45 2015 1221 bte@croxxmed.com

Locations
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Denmark
Aarhus Universitetshospital Recruiting
Aarhus, Denmark, 8200
Contact: Ellen-Margrethe Hauge, Proff. MD    +45 2478 6025    ellen.hauge@aarhus.rm.dk   
Norway
Diakonhjemmet Sykehus Recruiting
Oslo, Norway, 0370
Contact: Espen A Haavardsholm, Consultant, PhD    +47 2245 1500    Espen.Haavardsholm@diakonsyk.no   
Sponsors and Collaborators
SynAct Pharma Aps
Investigators
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Principal Investigator: Ellen-Margrethe Hauge, Professor Aarhus Universitetshospital
Principal Investigator: Espen A Haavardsholm, Concultant, PhD Diakonhjemmet Hospital
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Responsible Party: SynAct Pharma Aps
ClinicalTrials.gov Identifier: NCT04004429    
Other Study ID Numbers: SynAct-CS002
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021
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