Efficacy - Primary Endpoint During the Blinded Period
| Group | Value (Percentage of participants) |
|---|---|
| TransCon PTH 15 mcg | 50.0 |
| TransCon PTH 18 mcg | 40.0 |
| TransCon PTH 21 mcg | 60.0 |
| Placebo | 26.7 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name PaTH Forward
United States, Canada, Denmark, Germany, Italy, Norway
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
During the first four weeks of the trial, participants were randomly assigned to one of four groups: three groups received fixed doses of TransCon PTH and one group received placebo. TransCon PTH or placebo were administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors know who has been assigned to each group. After the four weeks, participants continued in the trial as part of a long-term extension period. During the extension, all participants received TransCon PTH, with the dose adjusted to their individual needs. This was a global trial that was conducted in the United States, Canada, Germany, Denmark, Italy and Norway.
Experimental
Double Blind: TransCon PTH 15 mcg
TransCon PTH 15 mcg delivered once daily by subcutaneous injection
Experimental
Double Blind: TransCon PTH 18 mcg
TransCon PTH 18 mcg delivered once daily by subcutaneous injection
Experimental
Double Blind: TransCon PTH 21 mcg
TransCon PTH 21 mcg delivered once daily by subcutaneous injection
Placebo comparator
Placebo
Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection
Experimental
Open-Label Extension Period: TransCon PTH
Participants who completed the 4-week double-blind period, continued into the open-label extension period and received treatment with TransCon PTH up to Week 266, with up to an initial 14 weeks of TransCon PTH titration and standard of care optimization, followed by approximately 248 weeks of individualized doses of TransCon PTH (allowable dose range: 6 to 60 mcg/day).
Outcomes the sponsor listed as primary.
Efficacy - Primary Endpoint During the Blinded Period
Time frame · Week 4
The percentage of subjects with albumin-adjusted serum calcium within the normal range, and spot morning fractional excretion of calcium (spot AM FECa) within normal range (≤2%) or a reduction by at least 50% from baseline, and not taking active vitamin D supplements, and taking ≤1000 mg/day of calcium supplements
Efficacy - Key Secondary Endpoint During the Blinded Period
Time frame · Week 4
The percentage of subjects with albumin-adjusted serum calcium within the normal range, and spot AM FECa within the normal range (≤2%) or a reduction by at least 50% from baseline, and not taking active vitamin D supplements, and taking ≤ 500 mg/day of calcium supplements
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage of participants) |
|---|---|
| TransCon PTH 15 mcg | 50.0 |
| TransCon PTH 18 mcg | 40.0 |
| TransCon PTH 21 mcg | 60.0 |
| Placebo | 26.7 |
| Group | Value (Percentage of participants) |
|---|---|
| TransCon PTH 15 mcg | 50.0 |
| TransCon PTH 18 mcg | 26.7 |
| TransCon PTH 21 mcg | 60.0 |
| Placebo | 20.0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Double Blind: TransCon PTH 15 mcgTransCon PTH 15 mcg delivered once daily by subcutaneous injection TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. | 0 / 14 | 0 / 14 | 6 / 14 |
| Double Blind: TransCon PTH 18 mcgTransCon PTH 18 mcg delivered once daily by subcutaneous injection TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. | 0 / 15 | 0 / 15 | 5 / 15 |
| Double Blind: TransCon PTH 21 mcgTransCon PTH 21 mcg delivered once daily by subcutaneous injection TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. | 0 / 15 | 0 / 15 | 7 / 15 |
| Double Blind: PlaceboPlacebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection Placebo for TransCon PTH: Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection. | 0 / 15 | 0 / 15 | 6 / 15 |
| Total TransCon PTH PeriodParticipants who completed the 4-week double blind treatment period in placebo and TransCon PTH groups, continued into the open-label extension period and received treatment with TransCon PTH up to Week 266. This period refers to total period of exposure to TransCon PTH. For participants randomized to TransCon PTH at enrollment, the "TransCon PTH Period" was the time from first dose of blinded TransCon PTH until final analysis in OLE period. The TransCon PTH Period for participants randomized to placebo at enrollment was the time from first exposure to TransCon PTH at the time of cross-over from placebo, until final analysis in the OLE period. | 0 / 59 | 8 / 59 | 57 / 59 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
3 studies on this page
Indexing hint: Randomized controlled trial · 2026
Rubin et al. 2026Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 7
PMID 41636590PMC13616104DOI 10.1093/jbmr/zjag013PUB-41636590
Indexing hint: Randomized controlled trial · 2023
Khan et al. 2023Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 81
PMID 36271471PMC10099823DOI 10.1002/jbmr.4726PUB-36271471
Indexing hint: Randomized controlled trial · 2022
Khan et al. 2022The Journal of clinical endocrinology and metabolismcited by 48
PMID 34347093PMC8684498DOI 10.1210/clinem/dgab577PUB-34347093
1 study on this page
Indexing hint: Randomized controlled trial · 2026
Rubin et al. 2026The Journal of clinical endocrinology and metabolismcited by 2
PMID 41365829PMC13017087DOI 10.1210/clinem/dgaf653PUB-41365829
Who could join, as posted.
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