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NCT06298032
A Study Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Persons
Phase 1 trial testing Olamkicept Part A in Inflammatory Gastrointestinal Diseases in 49 participants. Completed in 15 November 2024.
15 November 2024
Quick facts
| Lead sponsor | Ferring Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 20 February 2024 |
| Primary completion | 15 November 2024 |
| Estimated completion | 15 November 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Olamkicept Part A — full drug profile →
- Olamkicept Part B — full drug profile →
- Placebo
Conditions studied
- Inflammatory Gastrointestinal Diseases — all drugs for Inflammatory Gastrointestinal Diseases →
Sponsor
Ferring Pharmaceuticals — full company profile →
Who can join
Adults 18 to 45, male only, with Inflammatory Gastrointestinal Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor, and administered at lower doses (600 mg every 2nd week for 12 weeks) it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses (up to 2400 mg) to support the clinical development program. Our hypothesis is that treatment with higher doses of Olamkicept will result in greater clinical improvement for patients with inflammatory bowel diseases.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The role of IL-6 in thyroid eye disease: an update on emerging treatments.
Murdock J, Nguyen J, Hurtgen BJ, Andorfer C, et al · · 2025 · cited 4× · PMID 40297767 · DOI 10.3389/fopht.2025.1544436
Verify or expand the search:
- PubMed search for NCT06298032
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06298032 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ferring Pharmaceuticals
- Last refreshed: 19 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06298032.
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