Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis
Model scores of the 29,894 trials active now.
Model score 4% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (369 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2010-09-30, after 2008-08-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2010-09-30. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: cancerassociatedplacebodiseaseopinion
Phrases that lowered it: and safetyefficacy andhistorydermatitissafety of -
Accepts healthy volunteers: not given (lowers risk) · Who can join
-
Primary purpose: not given (lowers risk) · Design
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Responsible party: not given (raises risk) · Design
-
Phase: 2 (raises risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Design: not given (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports before start: 0 (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 0 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Disease area, psychiatry: No (lowers risk) · Disease area
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- not given (typical: 2)
- Allocation
- randomized
- Design
- not given (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- not given (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology, dermatology
- Drugs matched to FDA substances
- none matched
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A Study to Evaluate the Efficacy, Safety and Tolerability of CT327 in Atopic Dermatitis NCT01808157 · started 2013 · scored riskier than 14% of active trials completed
- Safety and Efficacy of DNK333 in Atopic Dermatitis Patients NCT01033097 · started 2009 · scored riskier than 15% of active trials completed
- A Phase 2 Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis NCT06058000 · started 2023 · scored riskier than 9% of active trials completed
- A Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis. NCT04836858 · started 2021 · scored riskier than 45% of active trials completed
- B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis NCT04490109 · started 2020 · scored riskier than 20% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.