Dermatomyositis MedDRA version: 19.1 Level: PT Classification code 10012503 Term: Dermatomyositis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: IMO-8400
Product Code: IMO-8400
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: IMO-8400
Sponsors
Idera Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Has signed the current, approved Informed Consent Form 2 Is 18 to 75 years of age (inclusive) at the time of consent 3 Has definite or probable DM based on the criteria of Bohan and Peter (Appendix 3; 1975a, 1975b) OR those patients who have all other definite or probable Bohan and Peter criteria but do not have heliotrope rash and Gottron’s signs/papules may still be included if they have one or more of the following: a) DM autoantibody (anti-Mi-2, anti-MDA5, anti-TIF1-gamma, anti-NXP-2, anti-Jo-1, anti-PL-12, anti-PL-7, anti-EJ, anti-KS, anti-OJ); at least 1 autoantibody must be present and documented in the patient’s medical record b) A classic DM associated skin change including at least one of the following: malar rash without sparing nasolabial folds, Shawl sign, V neck rash, periungal erythema, or mechanic’s hands; documented in the patient’s medical record 4 Has a CDASIv2-Activity score =15 at Visit 2 (Baseline) 5 Patients with muscle weakness are eligible; however, having muscle weakness is not mandatory. These patients have documented assessment of active muscle involvement as described in the protocol. 6 If on permitted concomitant medications at Screening, the therapy regimen can include one or more of the following: a) Stable dose of prednisone (or other oral equivalent) =20 mg/day (or =140 mg/week) for =4 weeks b) Stable regimen that does not exceed the approved dosages for =12 weeks of no more than 1 of the following non-steroidal immunomodulatory medication(s): intravenous immunoglobulin, mycophenolate mofetil, cyclophosphamide, cyclosporine, leflunomide, tacrolimus, methotrexate, azathioprine c) Stable regimen of topical treatments for scalp involvement for =3 weeks 7 Study participants must have a diagnostic evaluation for cancer if the diagnosis of DM was within 2 years prior to the Screening Visit. The evaluation should include either: a) All age- and gender-appropriate screening tests and a computed tomography (CT) of the chest, abdomen, and pelvis; OR b) Positron emission tomography and computed tomography (PET/CT) of the chest, abdomen, and pelvis. Note: If a diagnostic evaluation for cancer has not been performed within 2 years prior to the Screening Visit in patients for whom it is required, either a CT of the chest, abdomen, and pelvis should be performed, OR a PET/CT of the chest, abdomen, and pelvis if this is standard practice in the particular center. The diagnostic evaluation for cancer must be normal for a patient to meet this inclusion criterion 8 Study participants must have no evidence of active or latent TB after a diagnostic evaluation with a chest x-ray OR chest CT and 1 of the following: a) a purified protein derivative skin test, b) a QuantiFERON blood test or c) T-SPOT.TB blood test. If the diagnostic evaluation has not been performed within 12 weeks of the Screening Visit, it may be performed during the Screening Period (performed per Center for Disease Control guidelines. For the patient to be eligible, the result of the diagnostic evaluation should include a negative chest image and 1 of the following: a) a PPD skin test with =5-mm induration, or b) a negative (not detected) QuantiFERON result or c) a negative T-SPOT.TB blood test. If th
Exclusion criteria
Exclusion criteria: 1. Has ongoing severe dysphagia (e.g., requires a feeding tube) for the 3 months prior to Screening 2. Has known hypersensitivity to any oligodeoxynucleotide 3. Has a history of drug abuse within one year of screening, or evidence of drug abuse by urine drug screening 4. Has a history of alcohol abuse within one year of screening 5. Is pregnant (or intends to become pregnant within 6 months of last dose of study medication) or nursing 6. Has body weight >140 kg 7. Has any one of the following hepatitis serologic test results: a) Positive hepatitis B surface antigen test (HBsAg), or b) Positive hepatitis B core antibody test (anti-HBc) AND negative hepatitis B surface antibody (anti-HBs), or c) Positive hepatitis C virus antibody test (anti-HCV) 8. Has evidence of seropositive test in the patient’s medical records or is currently receiving treatment for human immunodeficiency virus (HIV)-1 or HIV-2 9. Has screening safety laboratory test meeting any of the following criteria: a) Hemoglobin 1.2 mg/dL in female patients and >1.5 mg/dL in male patients. Patients with serum creatinine values exceeding limits may be eligible for the study if their eGFRs are >60 mL/min f) Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) >5 times ULN (unless considered consistent with muscle origin and accompanied by gamma-glutamyl transferase (GGT) 1.5 times ULN h) Prothrombin time (PT) >1.5 times ULN i) C3 or C4 1+ 10. Has a diagnosis of Juvenile DM, IBM, drug-induced toxic myopathy, metabolic myopathy, dystrophy, cancer-associated DM , or connective tissue disease-associated DM (e.g., overlap syndrome) 11. Has received one or more of following prohibited treatments within the interval noted prior to Screening (Visit 1): a) Rituximab within 24 weeks (Note: patients who received rituximab are only eligible for inclusion if B-cell counts are confirmed to be within normal limits) b) Intravenous corticosteroids within 12 weeks c) Intravenous immunosuppressive drugs within 12 weeks d) Any other monoclonal antibody, biologic agent, or investigational agent within 12 weeks or 5 half-lives (whichever is longer) e) Antimalarials (e.g., hydroxychloroquine) within 36 weeks f) Topical corticosteroids (excluding scalp) within 2 weeks 12. Has evidence of or has required treatment for cancer (except for treated, non-invasive carcinoma of the skin or cured carcinoma-in-situ following discussion with Medical Monitor) within 5 years 13. Has other chronic or active significant medical conditions within 6 months prior to Screening including but not limited to: allogeneic organ transplant (e.g., solid organ, bone marrow, or stem cells); cardiac disease (e.g., unstable angina,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the safety and tolerability of IMO-8400 in adult patients with active dermatomyositis (DM) • To assess the effect of IMO-8400 on the cutaneous manifestations of DM ;Secondary Objective: Not applicable; Primary end point(s): Primary Safety and Tolerability Endpoints •Number of patients discontinuing treatment due to AEs •Frequency and severity of AEs •Physical examination findings, including vital signs •Standard laboratory safety tests including hematology, chemistry, coagulation and urinalysis •Assessment of ISRs •ECG findings •Laboratory safety assessments including CH50, C3, C4, troponin, CRP, albumin, globulin, A:G ratio, proteinuria, eGFR, and platelet count Primary Efficacy Endpoint •Change from baseline in mCDASIv2 Activity score ; Timepoint(s) of evaluation of this end point: Safety and Tolerability Endpoints: AEs reported and observed, assessment of ISRs, Vital Signs: weekly during Week 1 to Week 25, then at end of study visit on Week 29 Physical examination findings standard laboratory safety tests, ECG, laboratory safety assessments: every four weeks during Week 1-Week 25, then at end of study visit on Week 29 Efficacy Endpoint: CDASIv2: every four weeks during Week 1-Week 25. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -;Timepoint(s) of evaluation of this end point: - | — |
Countries
Czech Republic, Hungary, Sweden, United Kingdom, United States
Contacts
Public ContactClinical Trials Mailbox
Idera Pharmaceuticals, Inc.
Outcome results
None listed