Phase 2
Completed N=66
A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics
Source: ClinicalTrials.gov NCT02960490 ↗Enrolled (actual)
66
Serious AEs
4.8%
Results posted
Aug 2021
Primary outcomePrimary: Core Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 12 Based on Non-responder Imputation (NRI) — 27.3; 22.6 percentage of participants — p=0.621
Summary
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study in rheumatoid arthritis participants inadequately responding to biologics.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Core Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 12 Based on Non-responder Imputation (NRI) |
27.3; 22.6 | 0.621 |
| SECONDARY Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI |
13.3; 7.1; 7.1; 25.0; 15.4; 9.1 | — |
| SECONDARY Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) |
9.7; 11.7; 9.9; 12.8; 8.7; 11.6 | — |
| SECONDARY Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF |
7.1; 9.5; 8.9; 8.8; 7.0; 9.5 | — |
| SECONDARY Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF |
56.7; 55.9; 56.9; 60.3; 57.5; 52.5 | — |
| SECONDARY Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF |
56.2; 54.9; 55.6; 57.7; 57.2; 51.0 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF |
63.3; 57.9; 62.4; 54.0; 60.8; 56.4 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF |
0.90; 1.04; 0.88; 1.08; 0.85; 1.20 | — |
| SECONDARY Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF |
1.08; 2.50; 3.09; 1.68; 0.94; 1.83 | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF |
33.1; 44.4; 51.8; 35.3; 33.9; 41.2 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF |
5.479; 5.870; 5.951; 5.971; 5.460; 5.696 | — |
| SECONDARY Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF |
4.842; 5.194; 5.305; 5.318; 4.780; 5.033 | — |
| SECONDARY Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF |
29.767; 34.986; 33.750; 34.508; 28.431; 33.745 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF |
28.687; 32.486; 30.657; 32.833; 27.492; 31.918 | — |
| SECONDARY Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Aged ≥18 and 450 milliseconds [ms]) in repeated electrocardiogram examinations
- Females of childbearing potential who have a positive pregnancy test in the Screening or Observation Phase or are breastfeeding
- Females of childbearing potential who:
- Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation
- Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from being sexually active during the study period or for 28 days after study drug discontinuation
- Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation.
(NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal [amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause] or have been sterilized surgically [i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing]).
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 28 days after study drug discontinuation.
- Scheduled for surgery during the study
- Currently enrolled in another clinical study or used any investigational drug or device within 28 days (or 5× the half-life, whichever is longer) before informed consent
- Has been treated with E6011 or any biologics for use in RA that has not been approved
- Use of a psychotropic agent as recreational purpose other than therapeutic purpose
- Any history of a medical condition or a concomitant medical condition that in the opinion of the investigator or subinvestigator would compromise the participant's ability to safely complete the study
Data sourced from ClinicalTrials.gov (NCT02960490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.