Upadacitinib hemihydrate in Colitis, Ulcerative: ACTRN12626000839303 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 16 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 4
Clinical phase
Not yet recruiting
Recruitment status
50
Planned enrollment
Timing not reported
Primary-completion proxy
Executive view
ACTRN12626000839303 evaluates Upadacitinib hemihydrate in Colitis, Ulcerative. The disclosed sponsor is University of Melbourne, the design is Interventional, and the geographic footprint is Australia. The first listed primary endpoint is not reported, assessed over an unreported time frame.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for ACTRN12626000839303 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Colitis, Ulcerative landscape. Drug & Asset MCP drug_fetch was queried for Upadacitinib hemihydrate, while Company & Deal Intelligence MCP organization_fetch was queried for University of Melbourne.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| ACTRN12626000839303 | Upadacitinib hemihydrate | Phase 4 / Not yet recruiting | University of Melbourne | Australia | Timing not reported | |
| NCT07773948 | Mesalamine | Phase 4 / Not yet recruiting | Linköping University Hospital | Sweden | Any event of pouchitis at two years follow up defined as a Pouchitis Disease Activity Index (PDAI) of ≥7. Within two years of functioning restorative proctocolectomy | 2031-03-31 |
| NCT07767370 | Mesalamine | Early Phase 1 / Recruiting | Second Affiliated Hospital of Nanjing Medical University | China | Fecal calprotectin of patients 14 days after treatment compared to the baseline level baseline, 14 days post-drug administration | 2028-08-31 |
| NCT07760077 | QLS1510 | Phase 1 / Not yet recruiting | Shanghai Qilu Pharmaceutical Research Center Co., Ltd. | Geography not reported | Number of Participants with treatment-emergent adverse events (TEAEs) Up to Week 4 | 2027-01-30 |
| NCT07760831 | HRS-7085 | Phase 1 / Not yet recruiting | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Moldova | Adverse events (AEs) at Week 12 | 2027-04-01 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
ACTRN12626000839303 is a Phase 4, not yet recruiting study with 50 planned participants. Allocation is Randomised controlled trial, masking is not reported, and the intervention model is not reported.
The primary endpoint is “not reported” over “not reported.” The retrieved endpoint description is: Efficacy: clinical response[Lichtiger Activity Index Response, defined as a decline in the Lichtiger index by >3 points and an absolute score <10 for 2 consecutive days, without the need for rescue therapy. Day 5 of admission];Safety: adverse events [Descriptive recording of adverse events gathered from patient and electronic medical records, presented as percentage of events in each group Days 0 to 35 from date of admission];Feasibility: Completion of the study protocol requirements [Percentage of completed protocols in each group including completion of data collection from electronic medical records Day 35 fo….
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 50 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Colitis, Ulcerative. These records do not establish direct evidence for ACTRN12626000839303 unless the registration number matches.
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moder…
Phase 3; n=636; Proportion of Subjects Who Achieve Clinical Remission Per Modified Mayo Score at Week 8 = 10 Participants ; Proportion of Subjects Who Achieve Clinical Remission Per Modified Mayo Score at Week 8 = 63 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05507216
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moder…
Phase 3; n=639; Proportion of Subjects Who Achieve Clinical Remission Per Modified Mayo Score at Week 8 = 4 Participants ; Proportion of Subjects Who Achieve Clinical Remission Per Modified Mayo Score at Week 8 = 69 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05507203
A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjec…
Phase 2; n=107; Percentage of Participants Achieving Endoscopic Remission at Month 12 = 46.9 percentage of participants ; Percentage of Participants Achieving Endoscopic Remission at Month 12 = 54.5 percentage of participants Source: https://clinicaltrials.gov/ct2/show/results/NCT02782663
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Upadacitinib hemihydrate is indexed as Small molecule drug with JAK1 biology and a global stage of Approved. The asset profile lists AbbVie, Inc. as an originator or developer.
University of Melbourne is indexed in Australia with the website http://unimelb.edu.au. The University of Melbourne is an Australian public university located in Melbourne, Victoria. The record lists 39 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Upadacitinib hemihydrate is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: ACTRN12626000839303
Protocol source: https://anzctr.org.au/ACTRN12626000839303.aspx
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 16 September 2026.
Upadacitinib hemihydrate in Colitis, Ulcerative is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes the primary endpoint and Timing not reported the leading decision points.
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