1. To assess the safety, tolerability, and efficacy of ABBV-3373 administered every other week (eow) intravenously (IV) in subjects with moderately to severely active RA on background MTX.2. To compare clinical efficacy of ABBV-3373 with adalimumab…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in disease activity score (DAS)28 (C-reactive protein [CRP]) from
Baseline (BL) at Week 12 for ABBV-3373 and adalimumab.
Secondary outcome
1. Change in clinical disease activity index (CDAI) from BL at Week 12 for
ABBV-3373 and adalimumab.
2. Change in simplified disease activity index (SDAI) from BL at Week 12 for
ABBV-3373 and adalimumab.
3. Change in DAS28 erythrocyte sedimentation rate [ESR] from BL at Week 12 for
ABBV-3373 and adalimumab.
4. Proportion of subjects achieving a low disease activity (LDA) (DAS28 [CRP]
<=3.2) at Week 12 for ABBV-3373 and adalimumab.
5. Proportion of subjects achieving American College of Rheumatology (ACR) 50
at Week 12 for ABBV-3373 and adalimumab.
Background summary
TNFα antagonists as well as other biologics and targeted synthetic DMARDs
provide 50% improvement in arthritis scores (ACR50) for fewer than half of RA
subjects, even in combination with methotrexate (MTX), indicating that there
remains an unmet clinical need for improved therapies.
Glucocorticoid receptor modulators (GRMs) are potent drugs for treating many
inflammatory diseases, including RA. However, the full efficacy of GRM therapy
is not achieved with existing agents due to systemic side effects.
ABBV-3373 is an antibody-drug conjugate (ADC) being developed for the treatment
of immune-mediated inflammatory diseases including RA. As an ADC, ABBV-3373 has
the potential to deliver a highly potent anti-inflammatory payload selectively
to the activated immune cells, and meanwhile to minimize systemic exposure to
the free payload.
Study objective
1. To assess the safety, tolerability, and efficacy of ABBV-3373 administered
every other week (eow) intravenously (IV) in subjects with moderately to
severely active RA on background MTX.
2. To compare clinical efficacy of ABBV-3373 with adalimumab and to test the
concept that an anti-TNF antibody-GRM drug-conjugate has the potential to
provide superior efficacy than the traditional anti-TNF antibody in RA.
Study design
This is a randomized, double-blind, double-dummy, adalimumab active-controlled
(12-week) study.
Intervention
In the first 12 weeks of treatment, subjects will receive either ABBV-3373 and
the matching placebo for adalimumab SC eow or in the control arm the matching
placebo for ABBV-3373 IV and adalimumab eow. At Week 12, the administration of
ABBV-3373 will stop to assess the durability of the observed clinical effects
up to 24 weeks, however, subcutaneous administrations of adalimumab will
continue in the control arm for comparison.
Study burden and risks
There will be higher burden for the subjects participating in this trial
compared to their standard of care. The subjects will be visiting the hospital
more frequently. During these visits study procedures will be performed
including urine- and blood sampling, physical exam and completion of
questionnaires. They will be tested for TB, Hepatitis B and C and HIV.
Furthermore, an ECG will be performed for a maximum of 3 times and, if needed,
an X-ray will be performed. Subjects of childbearing potential should practice
a method of birth control. They will be tested for pregnancy as well. Subjects
may also experience side effects of the study medication.
Knollstrasse -
Ludwigshafen 67061
DE
Knollstrasse -
Ludwigshafen 67061
DE
Listed location countries
Age
Inclusion criteria
1. Adult male or female, between 18 and 75 years of age inclusive at Screening.
2. Subject has the clinical diagnosis of RA for > 3 months based on the 1987
ACR classification criteria or 2010 ACR/European League against Rheumatism
(EULAR) criteria.
3. Subject meets the following disease activity criteria: >= 4 swollen joints
(based on 28 joint count) and >= 4 tender joints (based on 28 joint count) at
Screening and BL Visits; and DAS28(CRP) >= 3.2 at Screening.
4. Subject has an incomplete response to MTX. Subjects must have been on oral
or parenteral MTX therapy >= 3 months and on a stable prescription of 15 to 25
mg/week (or >= 10 mg/week in subjects intolerant of MTX at doses >= 15 mg/week)
for >= 4 weeks prior to the first dose of study drug. Subject must be expected
to be able to continue on stable dose of MTX for the duration of study
participation.
Exclusion criteria
1. Subjects previously exposed to adalimumab or other anti-TNF biologics.
2. Subjects previously exposed to non-anti-TNF biologics or targeted synthetic
DMARDs for RA, with exception of subjects exposed for less than 3 months and
terminated not due to lack of efficacy or intolerability.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-003053-21-NL |
| ClinicalTrials.gov | NCT03823391 |
| CCMO | NL69938.056.19 |