Hypotheses

How a status is decided

A hypothesis is Confirmed when two or more controlled phase 3 trials met their main goal, or when one did and a medicine of the same approach is approved in the EU or the US for that use. With one positive phase 3 trial and no approval it is Supported by one trial. Analyses that only compare an active comparator with placebo, such as interferon beta against placebo inside a laquinimod trial, do not count as the tested medicine’s result.

Confirmed

Two or more controlled phase 3 trials met their main goal, or one did and a medicine of this approach is approved for this use.

Supported by one trial

One controlled phase 3 trial met its main goal. It needs a second trial or regulatory approval to count as confirmed.

Promising

Worked in a controlled phase 2 trial. A signal, not proof.

Mixed

Controlled trials disagree.

Results pending

Trials finished, but not all results are read yet.

Being tested

Trials are running now. No verdict yet.

Failed in phase 2

Controlled phase 2 trials did not meet their main goal for this group.

Failed in phase 3

Controlled phase 3 trials did not meet their main goal for this group. This does not rule out the mechanism in other groups or with other medicines.

No clear answer

Tried, but no controlled phase 2 or 3 result yet.

Not yet tested

Proposed or suggested by genetics. Not yet tested in MS.

Unread results can leave a status pending. Two or more phase 3 trials that met their goal, with none against, give a verdict even when an extension study at the same phase has no readable result.

“Failed in phase 3” applies to the patient group shown. A hypothesis can fail in primary progressive MS and work in relapsing MS.

Not yet tested items come from two places: proposed hypotheses, and genes linked to MS by human genetics that existing medicines act on but that have never been tried in MS.

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