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Drugs / BI 695501
last change May 2024 re-read 2 minutes ago

BI 695501

also known as adalimumab-adbm · Cyltezo

Monoclonal antibody

Developed for
rheumatoid arthritis · psoriasis · Crohn disease
Investigated by
Boehringer Ingelheim

Trials 11 · a red edge is where a trial was stopped

today NCT05203289 · Ph 1 NCT03210259 · Ph 3 NCT02871635 · Ph 3 NCT02899338 · Ph 1 NCT02850965 · Ph 3 NCT02640612 · Ph 3 NCT02636907 · Ph 2 NCT02606903 · Ph 1 NCT02137226 · Ph 3 NCT02045979 · Ph 1 NCT01505491 · Ph 1
2012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT05203289 Feb → Aug 2022 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT02899338 Sep 2016 → Feb 2017 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT02606903 Oct 2015 → Sep 2016 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT02045979 Jan → Jun 2014 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT01505491 Dec 2011 → Jul 2012 — Boehringer Ingelheim Completed No outcome recorded
Phase 21 trial
Phase 2 NCT02636907 Jan → Jun 2016 rheumatoid arthritis Boehringer Ingelheim Completed No outcome recorded
Phase 35 trials
Phase 3 NCT03210259 Jul 2017 → Apr 2019 psoriasis Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT02871635 Sep 2016 → Apr 2019 Crohn disease Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT02850965 Aug 2016 → Jan 2018 psoriasis Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT02640612 Jan 2016 → Nov 2017 rheumatoid arthritis Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT02137226 Jan 2015 → Mar 2016 rheumatoid arthritis Boehringer Ingelheim Completed No outcome recorded

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

FieldValueCited text
Known as BI 695501 “Pharmacokinetics and Safety of BI 695501” NCT02899338 ↗
10

NCT02850965 ↗

NCT02606903 ↗

NCT02636907 ↗

NCT02137226 ↗

NCT02871635 ↗

NCT02640612 ↗

NCT05203289 ↗

NCT03210259 ↗

NCT02045979 ↗

NCT01505491 ↗
Known as adalimumab-adbm “the biosimilar adalimumab-adbm (Cyltezo®), including pharmacokinetic (PK) profiles, immunogenicity, and safety profiles in healthy volunteers.” PMID 38739422 ↗ May 2024
Known as Cyltezo “the biosimilar adalimumab-adbm (Cyltezo®), including pharmacokinetic (PK) profiles, immunogenicity, and safety profiles in healthy volunteers.” PMID 38739422 ↗ May 2024
Modality Monoclonal antibody “BI 695501 is an FDA-approved biosimilar to adalimumab reference product (RP). VOLTAIRE-X was a randomized clinical trial to assess outcomes with a biosimilar monoclonal antibody” PMID 35934770 ↗ Aug 2022
Route Subcutaneous “BI 695501 single s.c injection” NCT01505491 ↗